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

July 7th, 2014 by admin in Humor, Quackery Exposed, Research
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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.

Do Childless Couples Have An Increased Risk Of Death And Mental Illness?

December 21st, 2012 by admin in Opinion, Research
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I hate scientific studies that don’t investigate the assumptions on which they’re based.  They do harm.  The findings slither around and get into the heads of people who treat people for the issues the research purports to understand.  And the misconceptions become protocol.  Here’s one example:

The Journal of Epidemiology and Community Health published an article declaring a connection between childlessness and increased risk of death and mental illness.

Among the findings:

• Having a child cut the risk of early death, particularly among women.
• The early death rate from circulatory disease, cancers, and accidents among childless women was four times as high as that among those who gave birth to their own child, and 50% lower among women who adopted.
• Similarly, rates of death were around twice as high among men who did not become parents, either biologically or through adoption.
• The prevalence of mental illness in couples who adopted kids was around half that of other parents.

What the study states but doesn’t investigate is that for their research they used:  “population-based health and social registers, we conducted a follow-up study of 21 276 childless couples in in vitro fertility treatment.”

Do you hear the sound of “WHAT!??!” beginning to reverberate?

Might it be that couples who have been living in the infertility system for months, maybe years and have had their original life script expectations erased, have had doctors and drugs and timetables invade their intimate time, have spent gobs of money, and have had repeated cycles of devastating disappointment may be in a very different state than couples who have CHOSEN not to have children?

And let me state my assumption up front.  Choosing not to have children is not dysfunctional.  It’s not a psychological condition.  It’s not an ethical/moral lapse.  It’s not a sign of immaturity or selfishness.  It’s a legitimate choice.

It may be that the researchers’ findings do apply to couples who undergo infertility treatment in order to have a child.

But there is harm in assuming that all couples who don’t have children are at higher risk for death and mental illness.

***

This post originally appeared at Barbara’s blog, In Sickness As In Health.

Eating Less Is More Important Than What You Eat

June 22nd, 2012 by Dr. Val Jones in Health Tips, Opinion
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I was raised by a health food zealot, and have been “eating clean” for most of my life. I have been an editor of a peer-reviewed nutrition and obesity journal, a food critic, and a dairy farmer. I am passionate about food – but I am also passionate about science. And I have to tell you, that for measurable health benefits, how much you eat is more important than what you eat.

I know this is controversial, and I’m certainly not saying that we should throw out all our leafy green veggies and grilled chicken and chow down on a diet of Twinkies and beer. But what I am saying is that the relative importance of food volume versus food quality has been misrepresented. We are focusing too much on specific nutrients and not enough on total caloric intake. I’d guess that what we eat is about 10% of the obesity problem, and how much we eat is 90% of the problem, but we spend 90% of our time talking about changing and improving what we eat rather than portion control strategies.

Consider these research-based findings :

1. The CDC has determined that 90% Americans get all the nutrients they need from the food they eat. Even “crappy” US diets actually do provide the minimum nutrients needed to avoid disease and malnutrition. I know this is surprising, but vitamins and supplements are simply not needed by most people.

2. Measurable health benefits occur from weight loss as small as 5-10% of total body weight. You don’t need to be a bikini model to achieve the health benefits of weight loss. You can decrease your blood pressure, sugar, and cholesterol with modest weight losses. In my opinion, leanness under about 25% body fat (for women) is mostly an aesthetic choice, not one of medical necessity.

3. Exercise benefits are largest at minimal levels. Going from sedentary to slightly active provides a larger health benefit than all additional increments of exercise. Thirty minutes of exercise, five times a week, is the minimum bar set by the Department of Health and Human Services. Anything beyond that is still valuable, but doesn’t decrease health risks by as much.

4. It matters more to lose weight, than it matters how you do it. Head-to-head studies of one diet versus another have repeatedly shown minimal differences in health benefits between the diet groups. The benefits occur from the weight loss, not from the manner in which it was lost.

This is all good news. Americans can achieve healthier outcomes with less effort than generally believed. Regular exercise, and a calorie-controlled diet (rather than rigidly controlling the macro and micro nutrients) are all that is required to substantially reduce the risk of many costly and unpleasant diseases. If you want to further optimize your health by eating a diet rich in fruits and veggies, whole grains, low-fat dairy, healthy fats, and lean protein please do so! But better to be a normal weight than obese due to eating too much of that healthy diet.

The bottom line is that you don’t have to give up eating the things you like, you just have to eat less of them. Even Olympian Carmelita Jeter eats Hostess cup cakes occasionally. And she’s the fastest woman in the world!

P.S. This blog post was inspired by a Twitter conversation with @Judith_Graham who said that the complicated issue of what to eat was too difficult to address in 140 character exchanges. Thank you, Judith!

P.P.S. Also, I’ve been thinking a lot about well-meaning but misguided (IMO) health policy issues raised by mayor Bloomberg’s ban on Big Gulps and the AMA’s endorsement of soda taxes. Bloomberg was pointing in the right direction (the size of the soda, not the soda itself was the problem), but I don’t believe you can regulate good behavior. Education and personal responsibility are the way to go.

Study Looks At Online Physician Ratings

January 6th, 2012 by Toni Brayer, M.D. in Research
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It’s time for some good news!   A study that looked at online patient ratings  about their physicians from 2004 through 2010 showed that the average physician rating was 9.3 out of 10.  That is amazingly high and shows that patients (at least the ones who posted on Dr.Score) are very content with the care they receive from their doctor.  Even though some patients will post a nasty comment about the doctor, the overall patient satisfaction is high.  Seventy percent of doctors earned a perfect 10.

The survey asked patients to Read more »

*This blog post was originally published at EverythingHealth*

The Truth About Weight Gain

January 5th, 2012 by RyanDuBosar in Research
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Consuming excess calories increases body fat, regardless of how many calories come from protein. High-protein diets do affect energy expenditure and storage of lean body mass, just not body fat storage.

To evaluate the effects of overconsumption of low-, normal-, and high-protein diets on weight gain, researchers conducted a single-blind, randomized controlled trial of 25 healthy, weight-stable adults in an inpatient metabolic unit in Baton Rouge, La. Patients were ages 18 to 35 with a body mass index between 19 and 30. The study was headed by George A. Bray, MD, MACP.

After consuming a weight-stabilizing diet for 13 to 25 days, participants were randomized to diets containing 5% of energy from protein (low protein), 15% (normal protein) or 25% (high protein). Only the kitchen staff who supervised participants while they were eating knew the assignments. There was no prescribed exercise, and alcohol and caffeine were restricted.

Patients were Read more »

*This blog post was originally published at ACP Internist*