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How To Create Medical Research To Support Bogus Therapies, In Nine Easy Steps

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Twenty years ago I started my job as ‘Professor of Complementary Medicine’ at the University of Exeter and became a full-time researcher of all matters related to alternative medicine. One issue that was discussed endlessly during these early days was the question whether alternative medicine can be investigated scientifically. There were many vociferous proponents of the view that it was too subtle, too individualised, too special for that and that it defied science in principle. Alternative medicine, they claimed, needed an alternative to science to be validated. I spent my time arguing the opposite, of course, and today there finally seems to be a consensus that alternative medicine can and should be submitted to scientific tests much like any other branch of health care.

Looking back at those debates, I think it is rather obvious why apologists of alternative medicine were so vehement about opposing scientific investigations: they suspected, perhaps even knew, that the results of such research would be mostly negative. Once the anti-scientists saw that they were fighting a lost battle, they changed their tune and adopted science – well sort of: they became pseudo-scientists (‘if you cannot beat them, join them’). Their aim was to prevent disaster, namely the documentation of alternative medicine’s uselessness by scientists. Meanwhile many of these ‘anti-scientists turned pseudo-scientists’ have made rather surprising careers out of their cunning role-change; professorships at respectable universities have mushroomed. Yes, pseudo-scientists have splendid prospects these days in the realm of alternative medicine.

The term ‘pseudo-scientist’ as I understand it describes a person who thinks he/she knows the truth about his/her subject well before he/she has done the actual research. A pseudo-scientist is keen to understand the rules of science in order to corrupt science; he/she aims at using the tools of science not to test his/her assumptions and hypotheses, but to prove that his/her preconceived ideas were correct.

So, how does one become a top pseudo-scientist? During the last 20 years, I have observed some of the careers with interest and think I know how it is done. Here are nine lessons which, if followed rigorously, will lead to success (… oh yes, in case I again have someone thick enough to complain about me misleading my readers: THIS POST IS SLIGHTLY TONGUE IN CHEEK).

  1. Throw yourself into qualitative research. For instance, focus groups are a safe bet. This type of pseudo-research is not really difficult to do: you assemble about 5 -10 people, let them express their opinions, record them, extract from the diversity of views what you recognise as your own opinion and call it a ‘common theme’, write the whole thing up, and - BINGO! – you have a publication. The beauty of this approach is manifold: 1) you can repeat this exercise ad nauseam until your publication list is of respectable length; there are plenty of alternative medicine journals who will hurry to publish your pseudo-research; 2) you can manipulate your findings at will, for instance, by selecting your sample (if you recruit people outside a health food shop, for instance, and direct your group wisely, you will find everything alternative medicine journals love to print); 3) you will never produce a paper that displeases the likes of Prince Charles (this is more important than you may think: even pseudo-science needs a sponsor [or would that be a pseudo-sponsor?]).
  2. Conduct surveys. These are very popular and highly respected/publishable projects in alternative medicine – and they are almost as quick and easy as focus groups. Do not get deterred by the fact that thousands of very similar investigations are already available. If, for instance, there already is one describing the alternative medicine usage by leg-amputated police-men in North Devon, and you nevertheless feel the urge of going into this area, you can safely follow your instinct: do a survey of leg-amputated police men in North Devon with a medical history of diabetes. There are no limits, and as long as you conclude that your participants used a lot of alternative medicine, were very satisfied with it, did not experience any adverse effects, thought it was value for money, and would recommend it to their neighbour, you have secured another publication in an alternative medicine journal.
  3. Take a sociological, anthropological or psychological approach. How about studying, for example, the differences in worldviews, the different belief systems, the different ways of knowing, the different concepts about illness, the different expectations, the unique spiritual dimensions, the amazing views on holism – all in different cultures, settings or countries? Invariably, you will, of course, conclude that one truth is at least as good as the next. This will make you popular with all the post-modernists who use alternative medicine as a playground for getting a few publications out. This approach will allow you to travel extensively and generally have a good time. Your papers might not win you a Nobel prize, but one cannot have everything.
  4. Do a safety study. It could well be that, at one stage, your boss has a serious talk with you demanding that you start doing what (in his narrow mind) constitutes ‘real science’. He might be keen to get some brownie-points at the next RAE and could thus want you to actually test alternative treatments in terms of their safety and efficacy. Do not despair! Even then, there are plenty of possibilities to remain true to your pseudo-scientific principles. By now you are good at running surveys, and you could, for instance, take up your boss’ suggestion of studying the safety of your favourite alternative medicine with a survey of its users. You simply evaluate their experiences and opinions regarding adverse effects. But be careful, you are on somewhat thinner ice here; you don’t want to upset anyone by generating alarming findings. Make sure your sample is small enough for a false negative result, and that all participants are well-pleased with their alternative medicine. This might be merely a question of selecting your patients cleverly. The main thing is that your conclusion is positive. If you want to go the extra pseudo-scientific mile, mention in the discussion of your paper that your participants all felt that conventional drugs were very harmful.
  5. Publish case reports. If your boss insists you tackle the daunting issue of therapeutic efficacy, there is no reason to give up pseudo-science either. You can always find patients who happened to have recovered spectacularly well from a life-threatening disease after receiving your favourite form of alternative medicine. Once you have identified such a person, you write up her experience in much detail and call it a ‘case report’. It requires a little skill to brush over the fact that the patient also had lots of conventional treatments, or that her diagnosis was assumed but never properly verified. As a pseudo-scientist, you will have to learn how to discretely make such irritating details vanish so that, in the final paper, they are no longer recognisable. Once you are familiar with this methodology, you can try to find a couple more such cases and publish them as a ‘best case series’ – I can guarantee that you will be all other pseudo-scientists’ hero!
  6. Publish a case series. Your boss might point out, after you have published half a dozen such articles, that single cases are not really very conclusive. The antidote to this argument is simple: you do a large case series along the same lines. Here you can even show off your excellent statistical skills by calculating the statistical significance of the difference between the severity of the condition before the treatment and the one after it. As long as you show marked improvements, ignore all the many other factors involved in the outcome and conclude that these changes are undeniably the result of the treatment, you will be able to publish your paper without problems.
  7. Rig the study design. As your boss seems to be obsessed with the RAE and all that, he might one day insist you conduct what he narrow-mindedly calls a ‘proper’ study; in other words, you might be forced to bite the bullet and learn how to plan and run an RCT. As your particular alternative therapy is not really effective, this could lead to serious embarrassment in form of a negative result, something that must be avoided at all cost. I therefore recommend you join for a few months a research group that has a proven track record in doing RCTs of utterly useless treatments without ever failing to conclude that it is highly effective. There are several of those units both in the UK and elsewhere, and their expertise is remarkable. They will teach you how to incorporate all the right design features into your study without there being the slightest risk of generating a negative result. A particularly popular solution is to conduct what they call a ‘pragmatic’ trial, I suggest you focus on this splendid innovation that never fails to produce anything but cheerfully positive findings.
  8. Play with statistics until you get the desired result. It is hardly possible that this strategy fails – but once every blue moon, all precautions turn out to be in vain, and even the most cunningly designed study of your bogus therapy might deliver a negative result. This is a challenge to any pseudo-scientist, but you can master it, provided you don’t lose your head. In such a rare case I recommend to run as many different statistical tests as you can find; chances are that one of them will nevertheless produce something vaguely positive. If even this method fails (and it hardly ever does), you can always home in on the fact that, in your efficacy study of your bogus treatment, not a single patient died. Who would be able to doubt that this is a positive outcome? Stress it clearly, select it as the main feature of your conclusions, and thus make the more disappointing findings disappear.
  9. Create confirmatory studies that follow your rigged design and faulty statistics. Now that you are a fully-fledged pseudo-scientist who has produced one misleading or false positive result after the next, you may want a ‘proper’ confirmatory study of your pet-therapy. For this purpose run the same RCT over again, and again, and again. Eventually you want a meta-analysis of all RCTs ever published. As you are the only person who ever conducted studies on the bogus treatment in question, this should be quite easy: you pool the data of all your trials and, bob’s your uncle: a nice little summary of the totality of the data that shows beyond doubt that your therapy works. Now even your narrow-minded boss will be impressed.

These nine lessons can and should be modified to suit your particular situation, of course. Nothing here is written in stone. The one skill any pseudo-scientist must have is flexibility.

Every now and then, some smart arse is bound to attack you and claim that this is not rigorous science, that independent replications are required, that you are biased etc. etc. blah, blah, blah. Do not panic: either you ignore that person completely, or (in case there is a whole gang of nasty skeptics after you) you might just point out that:

  • your work follows a new paradigm; the one of your critics is now obsolete,
  • your detractors fail to understand the complexity of the subject and their comments merely reveal their ridiculous incompetence,
  • your critics are less than impartial, in fact, most are bought by BIG PHARMA,
  • you have a paper ‘in press’ that fully deals with all the criticism and explains how inappropriate it really is.

In closing, allow me a final word about publishing. There are hundreds of alternative medicine journals out there to chose from. They will love your papers because they are uncompromising promotional. These journals all have one thing in common: they are run by apologists of alternative medicine who abhor to read anything negative about alternative medicine. Consequently hardly a critical word about alternative medicine will ever appear in these journals. If you want to make double sure that your paper does not get criticised during the peer-review process (this would require a revision, and you don’t need extra work of that nature), you can suggest a friend for peer-reviewing it. In turn, you can offer to him/her that you do the same to him/her the next time he/she has an article to submit. This is how pseudo-scientists make sure that the body of pseudo-evidence for their pseudo-treatments is growing at a steady pace.

***

Dr. Ernst is a PM&R specialist and the author of 48 books and more than 1000 articles in the peer-reviewed medical literature. His most recent book, Trick or Treatment? Alternative Medicine on Trial is available from amazon. He blogs regularly at EdzardErnst.com and contributes occasionally to this blog.

The Problem With Running Medical Information Through A Digital Intermediary

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In my last post I wrote about the communication difficulties caused by electronic medical records systems. The response on Twitter ranged from sentiments including everything from “right on, sister” to “greedy doctors are only complaining about EMRs because of their price tag.” The disconnect between policy wonk’s (and EMR vendor’s) belief in the transformative power of EMRs and exasperated clinician users of these products is jaw-dropping. Physicians are often labeled as obstinate dinosaurs, blocking progress, while policy wonks are considered by physicians to be living in an alternate reality where a mobile phone app could fix all that is wrong with the healthcare system.

Being on the dinosaur side, I thought I’d try a quick experiment/analogy to demonstrate that EMR dissatisfaction is not a mere cost artifact. To show what happens when a digital intermediary runs medical information through a translator, I selected a random paragraph about the epidemiology of aphasias from an article in Medscape. I copied and pasted it into Google translator and then ran it backwards and forwards a few times in different languages. In the end, the original paragraph (exhibit A) became the second paragraph (exhibit B):

Exhibit A:

“Not enough data are available to evaluate differences in the incidence and clinical features of aphasia in men and women. Some studies suggest a lower incidence of aphasia in women because they may have more bilaterality of language function. Differences may also exist in aphasia type, with more women than men developing Wernicke aphasia.”

Exhibit B:

“Prevalence and characteristics of men and women are expected to afasia is not enough information available. If afasia some studies, women work more, not less, because they show that the spoken language. There may be differences in the type of OST, women and men to develop more of a vernikke afasia, more.”

Although the B paragraph bears some resemblance to A, it is nearly impossible to determine its original meaning. This is similar to what happens to medical notes in most current EMRs (except the paragraph would be broken up with lab values and vital signs from the past week or two). If your job were to read hundreds of pages of B-type paragraphs all day, what do you think would happen? Would you enthusiastically adopt this new technology? Or would you give up reading the notes completely? Would you need to spend hours of your day finding “work-arounds” to correct the paragraphs?

And what would you say if the government mandated that you use this new technology or face decreased reimbursement for treating patients? What if you needed to demonstrate “meaningful use” or dependency and integration of the translator into your daily workflow in order to keep your business afloat? What if the scope of the technology were continually expanded to include more and more written information so that everything from lab orders to medication lists to hospital discharges, nursing summaries, and physical therapy notes, etc. were legally required to go through the translator first? And if you pointed out that this was not improving communication but rather introducing new errors, harming patients, and stealing countless hours from direct clinical care, you would be called “change resistant” or “lazy.”

And what if 68,000 new medical codes were added to the translator, so that you couldn’t advance from paragraph to paragraph without selecting the correct code for a disease (such as gout) without reviewing 150 sub-type versions of the code. And then what if you were denied payment for treating a patient with gout because you did not select the correct code within the 150 subtypes? And then multiply that problem by every condition of every patient you ever see.

Clearly, the cost of the EMR is the main reason why physicians are not willing to adopt them without complaint. Good riddance to the 50% of doctors who say they’re going to quit, retire, or reduce their work hours within the next three years. Without physicians to slow down the process of EMR adoption, we could really solve this healthcare crisis. Just add on a few mobile health apps and presto:  we will finally have the quality, affordable, healthcare that Americans deserve.

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