Clinical trials Complementary and alternative medicine Medicine Quackery Skepticism/critical thinking

Damn those microfascists demanding evidence-based medicine!

Damn you PZ!

(Heh, I haven’t gotten to say that since he shamed my profession by showing us an example of a certifiably loony young earth creationist physician running for Lt. Governor of South Carolina.)

This time around, I’m annoyed at PZ for pointing me in the direction of an article so absurd, so ridiculous, so full of postmodernistic appeals to other ways of knowing with respect to science that at first I thought that it had to be a parody of postmodernism in the form of, as PZ put it, suggesting that Foucault or Derrida should have as much value treating your cancer as evidence-based medicine. PZ happened to have found the article by way of Martin Rundkvist. (Martin is, by the way, a future host of the Skeptics’ Circle; so I guess I can’t come down too hard on him; that, however, doesn’t let PZ, Ophelia, or Ben off the hook for subjecting me to this as I perused my blog list this morning.)

Why am I so irritated? Because of PZ’s and other bloggers’ pointing this out, I ended up reading this article:

Holmes D, SJ Murray, A Perron, and G Rail. Deconstructing the evidence-based discourse in health sciences: Truth, power, and fascism. Int J Evid Based Healthcare 4:180-186 (2006).

I’m sure I lost thousands of neurons as a result, and I’m pissed. If I’m going to lose some neurons, I at least want it to be in the course of something pleasurable, such as quaffing several fine beers, rather than plowing through pseudointellectual tripe like this. Because of references to Mussulini, Hitler, and fascism, I came just this close to writing yet another Hitler Zombie piece about this thing, but then I decided that this wasn’t even worthy of an appearance by the Undead Corporal Führer, as such an appearance would give this article more dignity than it deserves. Unfortunately, as ScienceBlogs‘ resident apologist for evidence-based medicine, I have little choice but to comment on this, as I’m sure it will be turning up on altie websites and on Usenet very soon. So, Holmes et al, you want to “deconstruct” evidence-based medicine (EBM)? There’s only one response to that, and that’s a little “deconstruction” of your article, done with Respectful Insolence™, of course?

So, let’s start out with the abstract:

Background: Drawing on the work of the late French philosophers Deleuze and Guattari, the objective of this paper is to demonstrate that the evidence-based movement in the health sciences is outrageously exclusionary and dangerously normative with regards to scientific knowledge. As such, we assert that the evidence-based movement in health sciences constitutes a good example of microfascism at play in the contemporary scientific arena.

Objective: The philosophical work of Deleuze and Guattari proves to be useful in showing how health sciences are colonised (territorialised) by an all-encompassing scientific research paradigm – that of post-positivism – but also and foremost in showing the process by which a dominant ideology comes to exclude alternative forms of knowledge, therefore acting as a fascist structure.

Conclusion: The Cochrane Group, among others, has created a hierarchy that has been endorsed by many academic institutions, and that serves to (re)produce the exclusion of certain forms of research. Because ‘regimes of truth’ such as the evidence-based movement currently enjoy a privileged status, scholars have not only a scientific duty, but also an ethical obligation to deconstruct these regimes of power.

Geez, I had no idea that the Cochrane Collaboration was so amazingly powerful. Perhaps we in medicine should put them right up there with the Masons and the Illuminati. In any case, I may not know much philosophy, but I know Grade A bullshit when I see it. Microfascist that I apparently am for liking science and evidence-based medicine, let’s see if I can place my jackboot right on the throat of this thing, apply sufficient pressure to make it gasp for air, and then apply my fascistic truncheon liberally to its face, all the while resenting that the authors apparently didn’t consider EBM enough of a threat to label it real fascism. (I’ll leave it to the postmodernist authors of the paper to figure out whether I’m being metaphorical or not.) Because this article is such an incredibly–shall we say?–target rich environment, I’ll have to confine my pummeling to a few choice bits, lest this deconstruction swell to proportions beyond even my usual long-windedness.

Basically, this entire article is a huge appeal to other ways of knowing, coupled with massive straw men arguments, with a few other logical fallacies sprinkled in liberally for seasoning. The article begins:

We can already hear the objections. The term fascism represents an emotionally charged concept in both the political and religious arenas; it is the ugliest expression of life in the 20th century. Although it is associated with specific political systems, this fascism of the masses, as was practised by Hitler and Mussolini, has today been replaced by a system of microfascisms – polymorphous intolerances that are revealed in more subtle ways. Consequently, although the majority of the current manifestations of fascism are less brutal, they are nevertheless more pernicious.

You can almost hear the authors rubbing their hands together and cackling at being so…contrary, so…naughty, so…against the old stodgy scientists who think that we can actually know or measure reality with something close to objectivity. In other words, they’re just throwing in the comparison because it’s inflammatory. They then state their objective:

Drawing in part on the work of the late French philosophers Deleuze and Guattari the objective of this paper is to demonstrate that the evidence-based movement in the health sciences is outrageously exclusionary and dangerously normative with regards to scientific knowledge. As such, we assert that the evidence-based movement in health sciences constitutes a good example of microfascism at play in the contemporary scientific arena.

Yes, I suppose that one would find EBM to be “outrageously exclusionary” if one is a quack. But let’s get to the meat (or what passes for meat in this article). First, here’s the straw man that the authors harp on over and over and over:

As a global term, EBHS (evidence-based health sciences) reflects clinical practice based on scientific inquiry. The premise is that if healthcare professionals perform an action, there should be evidence that the action will produce the desired outcomes. These outcomes are desirable because they are believed to be beneficial to patients. Evidence-based practice derives from the work of Archie Cochrane, who argued for randomised controlled trials (RCTs being the highest level of evidences) as a means of ensuring healthcare cost containment, among other reasons. In 1993, the Cochrane Collaboration, serving as an international research review board, was founded to provide clinicians with a resource aimed at increasing clinician-patient interaction time by facilitating clinicians’ access to valid research. The Cochrane database was established to provide this resource, and it comprises a collection of articles that have been selected according to specific criteria. For example, one of the requirements of the Cochrane database is that acceptable research must be based on the RCT design; all other research, which constitutes 98% of the literature, is deemed scientifically imperfect.

Uh, no. Not exactly. While it is true that randomized clinical trials (preferably double-blinded) are considered a very high form of evidence; it does not follow that all other research is “scientifically imperfect,” simply for the reason that RCTs are not considered “perfect.” No science is, nor does the Cochrane Collaboration insist on or use only RCTs in formulating its literature reviews. True, there are some “true believers” who do push rigid EBM as a panacea, but they are definitely in the minority and tend to be viewed skeptically among most other EBM advocates. In any case, from the above, it’s pretty clear that the authors have no clue what EBM really is, and they demonstrate further how little they understand as they continue:

Consequently, EBHS comes to be widely considered as the truth. When only one method of knowledge production is promoted and validated, the implication is that health sciences are gradually reduced to EBHS. Indeed, the legitimacy of health sciences knowledge that is not based on specific research designs comes to be questioned, if not dismissed altogether. In the starkest terms, we are currently witnessing the health sciences engaged in a strange process of eliminating some ways of knowing. EBHS becomes a ‘regime of truth’, as Foucault would say – a regimented and institutionalised version of ‘truth’.

No, EBM does not–I repeat–does not represent itself, nor is it represented as the “truth,” nor is the Cochrane Collaboration this big, monolithic organization that tries to control this “truth” (which is what the article doesn’t just imply but almost comes right out and says explicitly–hence all the references to “fascism” and “microfascism”). This is what the Cochrane Collaboration is:

The Cochrane Collaboration is an international, non-profit, independent organisation, established to ensure that up-to-date, accurate information about the effects of healthcare interventions is readily available worldwide. It produces and disseminates systematic reviews of healthcare interventions, and promotes the search for evidence in the form of clinical trials and other studies of the effects of interventions.

And this is what it does:

The Cochrane Collaboration prepares Cochrane Reviews and aims to update them regularly with the latest scientific evidence. Members of the organisation (mostly volunteers) work together to provide evidence to help people make decisions about health care. Some people read the healthcare literature to find reports of randomised controlled trials; others find such reports by searching electronic databases; others prepare and update Cochrane Reviews based on the evidence found in these trials; others work to improve the methods used in Cochrane Reviews; others provide a vitally important consumer perspective; and others support the people doing these tasks.

Ooooh. Scary. Damn those Cochrane fascists! Clever little jackbooted brownshirts that they are, they’ve even coopted diversity:

The Cochrane Collaboration is committed to involving and supporting people of different skills and backgrounds, to reducing barriers to contributing, and to encouraging diversity. A document entitled ‘Cross-cultural team working within The Cochrane Collaboration’ gives advice on communicating with people from other cultures.

Even worse, they’ve published a document suggesting how to take into account other cultures and other ways of thinking. Will they stop at nothing?

The entire premise of this paper rests on a straw man, namely that the EBM as epitomized by the Cochrane Collaboration (which, when you come right down to it, is simply an organization that puts together reviews of the best current scientific evidence for and against various therapies) has some sort of over-reaching control over all of EBM and how medicine is practiced. In actuality, medicine would probably be better if the Cochrane Collaboration did have that kind of control, as far too much of medicine is still not as evidence-based. as it should be However, for all its faults, conventional medicine is certainly far more evidence-based than anything in “alternative” medicine, and that’s a good thing. As for me, if we’re talking about treatments that impact my health, I’d like to know what the evidence is that they actually work. Wouldn’t you?

Instead of the parody of EBM that the authors of this utterly ridiculous article present, let’s look at what EBM actually is:

Evidence-based medicine is the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence-based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research. By individual clinical expertise we mean the proficiency and judgement that individual clinicians acquire through clinical experience and clinical practice. Increased expertise is reflected in many ways, but especially in more effective and efficient diagnosis and in the more thoughtful identification and compassionate use of individual patients’ predicaments, rights, and preferences in making clinical decisions about their care. By best available external clinical evidence we mean clinically relevant research, often from the basic sciences of medicine, but especially from patient centred clinical research into the accuracy and precision of diagnostic tests (including the clinical examination), the power of prognostic markers, and the efficacy and safety of therapeutic, rehabilitative, and preventive regimens. External clinical evidence both invalidates previously accepted diagnostic tests and treatments and replaces them with new ones that are more powerful, more accurate, more efficacious, and safer.

Good doctors use both individual clinical expertise and the best available external evidence, and neither alone is enough. Without clinical expertise, practice risks becoming tyrannised by evidence, for even excellent external evidence may be inapplicable to or inappropriate for an individual patient. Without current best evidence, practice risks becoming rapidly out of date, to the detriment of patients.

Sounds dangerously fascistic, doesn’t it?

And let’s look at what EBM is not:

Evidence-based medicine is not “cook-book” medicine. Because it requires a bottom-up approach that integrates the best external evidence with individual clinical expertise and patient-choice, it cannot result in slavish, cook-book approaches to individual patient care. External clinical evidence can inform, but can never replace, individual clinical expertise, and it is this expertise that decides whether the external evidence applies to the individual patient at all and, if so, how it should be integrated into a clinical decision. Similarly, any external guideline must be integrated with individual clinical expertise in deciding whether and how it matches the patient’s clinical state, predicament, and preferences, and thus whether it should be applied. Clinicians who fear top-down cook-books will find the advocates of evidence-based medicine joining them at the barricades.

Gee, this doesn’t much sound like the “fascism” (or “microfascism”) that the authors claim is at the root of EBM. Both clinical experience must be guided by the best available scientific and clinical evidence, but that doesn’t mean that such evidence will devolve into “cookbook” medicine. True, we have developed a number of diagnostic and treatment algorithms from EBM, but these algorithms can never take into account the wide range of possible clinical presentations, and patient preferences must always be taken into account. It is also true that, in overzealous hands, EBM can come dangerously close to cookbook medicine, which would be a valid criticism. However, these authors have gone so over-the-top by labeling EBM as fascism that any hint of a reasonable critique of EBM has dissappeared in a cloud of postmodernist jargon and references to totalitarianism.

Evidence-based medicine is not cost-cutting medicine. Some fear that evidence-based medicine will be hijacked by purchasers and managers to cut the costs of health care. This would not only be a misuse of evidence-based medicine but suggests a fundamental misunderstanding of its financial consequences. Doctors practising evidence-based medicine will identify and apply the most efficacious interventions to maximise the quality and quantity of life for individual patients; this may raise rather than lower the cost of their care.

Indeed not. Let’s say several RCTs suggest that, for instance, MRI is better for screening for breast cancer in certain populations than traditional mammography. That would very likely raise the cost of care, at least in the short run. There is also no guarantee that the money saved from the more cancers caught at an early stage would balance out with the cost of the far more expensive MRI as a screening test, which might mean that costs would rise in the long run as well.

But here’s the biggest stompdown of this paper’s intentionally constructed straw man of EBM:

Evidence-based medicine is not restricted to randomised trials and meta-analyses. It involves tracking down the best external evidence with which to answer our clinical questions. To find out about the accuracy of a diagnostic test, we need to find proper cross-sectional studies of patients clinically suspected of harbouring the relevant disorder, not a randomised trial. For a question about prognosis, we need proper follow-up studies of patients assembled at a uniform, early point in the clinical course of their disease. And sometimes the evidence we need will come from the basic sciences such as genetics or immunology. It is when asking questions about therapy that we should try to avoid the non-experimental approaches, since these routinely lead to false-positive conclusions about efficacy. Because the randomised trial, and especially the systematic review of several randomised trials, is so much more likely to inform us and so much less likely to mislead us, it has become the “gold standard” for judging whether a treatment does more good than harm. However, some questions about therapy do not require randomised trials (successful interventions for otherwise fatal conditions) or cannot wait for the trials to be conducted. And if no randomised trial has been carried out for our patient’s predicament, we follow the trail to the next best external evidence and work from there.

This point is particularly relevant to doing clinical trials my specialty, surgery. Let’s take an acutely hemorrhaging patient. It doesn’t take an RCT to tell that taking the patient to the operating room to stop the hemorrhage will save the patient’s life. Or consider appendicitis. It doesn’t take an RCT to determine that removing the appendix in the case of acute appendicitis will result in far more people surviving than not operating. Indeed many surgical problems cannot easily be directly addressed by RCTs, at least not entirely ethically. For example, consider a test of doing a procedure versus not doing a procedure for a certain condition. It’s impossible to blind the patients as to which group they are in, as one group would be getting an operation and the other wouldn’t be. The only way you could truly blind the groups would be to do a sham operation on the control group–which leads to all sorts of ethical difficulties. Even then, the physicians would not be blinded to the treatment groups; they would know which patients got a real operation and which got a sham operation. (Even so, some groups have managed to do such trials.) Finally, there is the issue of operator skill; some surgeons are just better at some operations than others. If you’re doing a randomized trial to compare one operation against another for the treatment of a disease, you can never be 100% sure that differences observed were due to differences in the operation or technical differences in the skills of the surgeons. That’s why large numbers are often needed. The fact is, in surgery, much of the evidence upon which we base our clinical decisions does not come from classical double-blinded randomized studies. That does not make it any less evidence-based than medical oncology, where a great deal of the evidence comes from randomized, double blind, clinical trials, simply because it’s much easier to do such trials when what is being compared are two different drugs, rather than two different operations. In all of these cases no trial can take into account the multiplicity of variables that can impact on any single patient. A clinician brings his or her skills and experience into the mix, particularly when the evidence from EBM is sketchy or conflicting.

What we’re really looking at here, I must emphasize again, is an appeal to a different way of knowing:

We believe that health sciences ought to promote pluralism – the acceptance of multiple points of view. However, EBHS does not allow pluralism, unless that pluralism is engineered by the Cochrane hierarchy itself. Such a hegemony makes inevitable the further ‘segmentation’ of knowledge (i.e. disallowing multiple epistemologies), and further marginalise many forms of knowing/knowledge.

Ah, yes. “Pluralism.” Whatever that means when it comes to scientific evidence. Does that mean that unscientific bunk like homeopathy should be considered as deserving of equal consideration as EBM, all in the name of “pluralism”? Personally, when it comes to pseudoscientific crap like this, EBM should be “outrageously exclusionary.” However, even more than the “exclusionary” nature of EBM, what really seems really to bother the authors is the language of EBM and science, presumably because of its emphasis on evidence, reason, and fact:

We believe that EBM, which saturates health sciences discourses, constitutes an ossified language that maps the landscape of the professional disciplines as a whole. Accordingly, we believe that a postmodernist critique of this prevailing mode of thinking is indispensable. Those who are wedded to the idea of ‘evidence’ in the health sciences maintain what is essentially a Newtonian, mechanistic world view: they tend to believe that reality is objective, which is to say that it exists, ‘out there’, absolutely independent of the human observer, and of the observer’s intentions and observations. They fondly point to ‘facts’, while they are forced to dismiss ‘values’ as somehow unscientific. For them, this reality (an ensemble of facts) corresponds to an objectively real and mechanical world. But this form of empiricism, we would argue, fetishises the object at the expense of the human subject, for whom this world has a vital significance and meaning in the first place. An evidence-based, empirical world view is dangerously reductive insofar as it negates the personal and interpersonal significance and meaning of a
world that is first and foremost a relational world, and not a fixed set of objects, partes extra partes.

This is simply the age-old complaint that modern medicine doesn’t sufficiently value the humanity of the patient, that it’s cold and uncaring, interested only in reason and science, a complaint that has been around ever since we first started to base medical practice on science rather than folklore. I applaud these postmodernist author, though, for showing admirable restraint in refraining from doing what I expected and mentioning Dr. Mengele as a natural consequence of the fascistic scientific world view in which an objective reality is acknowledged. Besides, the universe doesn’t give a damn what we humans believe about it. Gravity will still cause you to tumble to the ground, whether you believe in it or not. Cancer cells don’t pay attention to the observer’s intentions and observations. Neither do microbes. As science has shown us, they do, however, pay attention to chemotherapeutics and antibiotics.

Indeed, the entire reason for the evolution of medicine from empirical, experience-based treatments to EBM comes from the very fact that the old ways were prone to a number of biases. The placebo effect guarantees that almost any intervention will make some proportion of patients with a given condition feel better, at least transiently. That’s the main reason for double-blinding and randomization when possible. Many diseases are either self-limited or their course waxes and wanes. If a patient tries something (or a doctor tries something on a patient) right before the disease symptoms wane, he or she will likely falsely attribute the clinical improvement to whatever was done right before, even though the intervention may or may not have had anything to do with the patient’s improvement! Confirmation bias means that, if you expect a treatment to work, your tendency, unintentional but real, will be to remember bits of evidence that fit with what you expect and to disregard or forget those that contradict what you expect. Because human observation is so fallable and so easily able to misrepresent objective reality is exactly what the scientific method corrects for. There are many other such pitfalls.

Here’s where PZ thought that the authors started to make sense, and they do, sort of, but they also show just how little they understand what is and is not EBM:

Of course, we do not wish to deny the material and objective existence of the world, but would suggest, rather, that our relation to the world and to others is always mediated, never direct or wholly transparent. Indeed, the sociocultural forms of this mediation would play a large part in the way the world appears as full of significance. Empirical facts alone are quantities that eclipse our qualitative and vital being-in-the-world. For example, how should a woman assign meaning to the diagnosis she just received that, genetically, she has a 40% probability of developing breast cancer in her lifetime? What will this number mean in real terms, when she is asked to evaluate the meaning of such personal risk in the context of her entire life, a life whose value and duration are themselves impossible factors in the

EBM never claimed to tell a woman how to “assign meaning” to a diagnosis of a genetic mutation that predisposes her to breast cancer and gives her a 40% chance of developing it in her lifetime. That’s not what it’s designed to do, nor should it be. “Meaning” is something only humans can provide. What EBM does do is to provide this woman with the tools to help her to assign meaning to that diagnosis herself and to decide, with the help of her doctor, what to do about it! Let’s say that EBM informs this woman that she has a 40% chance of developing breast cancer. Further, let’s say that it ca also tell her that prophylactic bilateral mastectomies combined with removal of the ovaries can reduce her risk by 20-fold or more. Only this woman can decide how much her breasts and ovaries mean to her as a woman. Some women will opt for removing their breasts to prevent cancer, even though without the surgery they are still more likely than not to avoid cancer. Others will decide to take their chances, often because they don’t want to alter their bodies. Without the information that EBM provides, the woman would likely never have the opportunity to weigh the risks and decide to act or not. She would simply either develop cancer or not and die of it or not. In this particular case, EBM is empowering, and a skillful clinician will take into account such a diagnosis in the context of the rest of the patient’s life. In other words, taking into account the totality of the patient’s life is not incompatible with EBM.

Basically, the entire article is, from start to finish, one long extended rant about the Man keeping down those “other ways of knowing” or (as the authors put it) other epistemologies. Just check out this hilarious penultimate paragraph if you don’t believe me:

The evidence-based enterprise invented by the Cochrane Group has captivated our thinking for too long, creating for itself an enchanting image that reaches out to researchers and scholars. However, in the name of efficiency, effectiveness and convenience, it simplistically supplants all heterogeneous thinking with a singular and totalising ideology. The all-embracing economy of such ideology lends the Cochrane Group’s disciples a profound sense of entitlement, what they take as a universal right to control the scientific agenda. By a so-called scientific consensus, this ‘regime of truth’ ostracises those with ‘deviant’ forms of knowledge, labelling them as rebels and rejecting their work as scientifically unsound. This reminds us of a famous statement by President George W Bush in light of the September 11 events: ‘Either you are with us, or you are with the terrorists’. In the context of the EBM, this absolutely polarising world view resonates vividly: embrace the EBHS or else be condemned as recklessly non-scientific.

Uh, no. Not exactly. But nice try. The authors do, however, get points for not only mentioning Hitler and Mussolini at the beginning of the article, but George W. Bush at the end while throwing in digs at “disciples” of the discipline they detest. In particular, they get points for this amazingly over-the-top conclusion:

When the pluralism of free speech is extinguished, speech as such is no longer meaningful; what follows is terror, a totalitarian violence. We must resist the totalitarian program – a program that collapses words and things, a program that thwarts all invention, a program that robs us of justice, of our meaningful place in the world, and of the future that is ours to forge together. Paradoxically, perhaps, an honest plurality of voices will open up a space of freedom for the radical singularity of individual and disparate knowledge(s). The endeavour is always a risk, but such a risk is part of the human condition, and it is that without which there couldbe no human action and no science worthy of the name.

Help, help! I’m being repressed!

The sad thing is, the can be legitimate critiques of EBM, mainly that sometimes it can be too rigidly algorithm-based and does not account for all variables. EBM is also notoriously difficult to apply in psychiatry, as well. Unfortunately, the authors here equate the quite reasonable insistence at the heart of EBM on, wherever possible, objective evidence from basic science and clinical studies to support the treatments we as doctors recommend to our patients with fascism and totalitarianism, all using pseudointellectual jargon and postmodernist posturing. Using their “other ways of knowing” or other epistemologies, it would be difficult to determine what is and is not quackery in medicine. Of course, that’s probably the point. In any case, just because EBM has shortcomings is not a reason to give a similar level of deference to non-evidence-based “other ways of knowing” as we give to EBM. For that to happen, these other ways of knowing would have to prove themselves to be at least close to being as predictive as EBM. They can’t.

How this oddity ended up in the medical literature is puzzling, but maybe it shouldn’t be. The International Journal of Evidence-based Healthcare is a rather obscure journal that, as far as I can tell, isn’t even indexed by Medline. Perhaps the editors thought that a little controversy would get people to read their journal.

It worked, I suppose. However, to me provoking ridicule from the blogosphere and from physicians who try to practice evidence-based medicine (even when they don’t even realize that that is what they are doing) is not a good way to build readership and credibility.

By Orac

Orac is the nom de blog of a humble surgeon/scientist who has an ego just big enough to delude himself that someone, somewhere might actually give a rodent's posterior about his copious verbal meanderings, but just barely small enough to admit to himself that few probably will. That surgeon is otherwise known as David Gorski.

That this particular surgeon has chosen his nom de blog based on a rather cranky and arrogant computer shaped like a clear box of blinking lights that he originally encountered when he became a fan of a 35 year old British SF television show whose special effects were renowned for their BBC/Doctor Who-style low budget look, but whose stories nonetheless resulted in some of the best, most innovative science fiction ever televised, should tell you nearly all that you need to know about Orac. (That, and the length of the preceding sentence.)

DISCLAIMER:: The various written meanderings here are the opinions of Orac and Orac alone, written on his own time. They should never be construed as representing the opinions of any other person or entity, especially Orac's cancer center, department of surgery, medical school, or university. Also note that Orac is nonpartisan; he is more than willing to criticize the statements of anyone, regardless of of political leanings, if that anyone advocates pseudoscience or quackery. Finally, medical commentary is not to be construed in any way as medical advice.

To contact Orac: [email protected]

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