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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.

All You Need To Know About Dr. Oz And The Dietary Supplement Scandal

June 23rd, 2014 by Dr. Val Jones in Announcements, Quackery Exposed
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Comedian John Oliver did an excellent job explaining everything that’s wrong with the Dr. Oz show and the dietary supplement industry. Please watch this video for a good laugh:

I’ve been warning folks about Dr. Oz for many years – and I hope that John reaches more people with his message.

To be fair, there are reputable companies who manufacture safe and effective vitamins and supplements too, as I have noted here.

Eat To Save Your Life: Another Half-True Diet Book

December 24th, 2012 by Dr. Val Jones in Book Reviews, Quackery Exposed
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I am hesitant to review diet books because they are so often a tangled mess of fact and fiction. Teasing out their truth from falsehood is about as exhausting as delousing a long-haired elementary school student. However, after being approached by the authors’ PR agency with the promise of a book that contains science-based nutrition information I decided to agree to the review. This is how the book was described to me in an email:

In their provocative new book, Eat to Save Your Life, best-selling authors Dr. Jerre Paquette and Gloria Askew, RRN, sort through the piles of information and misinformation about nutrition to reveal the true connection between food and health. Fed up with the advertising hype and conflicting nutritional advice, the duo provides common sense explanations for consumers everywhere who are looking to make smart nutritional choices.

Unfortunately, I was sold (quite predictably) a bill of goods. And rather than ignore the book and simply not do a review, I figured that maybe a negative review would reduce the number of incoming PR requests for future tomes of pseudoscience. In the end, I’ll probably just become the focus of personal attacks by dedicated proponents of various snake oils.

That being said, I thought it might be somewhat instructive to remind Better Health readers of certain basic “warning signs of pseudoscience” that I accidentally overlooked in agreeing to review the book. For a more complete review of similar “signs” I highly recommend Dr. David Gorski’s 2007 classic, humorous take on predictable arguments and behaviors of alternative medicine proponents (written in the style of comedian Jeff Foxworthy).  As for me, I tend to think of much of the world of integrative medicine as a militant group of bakers eager to add odd, inert and occasionally toxic substances to cake recipes.

And so, without further ado, here is a small sample of what authors Askew and Paquette have added to their half-true diet book recipe:

• The “one true cause” fallacy: The book opens with an interesting review of vitamin C deficiency, noting that it (apparently) took the British Royal Navy 40 years before they accepted that the treatment for scurvy was citrus extract (rather than flogging). Citing this incident as an example of nutritional deficiency leading to life-threatening illness,  it’s a short ride to the “one true cause” fallacy whereby the authors postulate that there are untold numbers of modern diseases caused by unrecognized nutritional deficiency syndromes. Nutritional deficiency may be the one true cause of most diseases, you see.
• The appeal to research without references. Countless appeals are made to “mounting evidence” of this and that (arthritis being caused primarily by food-related inflammation for example), either without reference footnotes, or with mentions of sources of dubious credibility (such as the Canadian Association of Naturopathic Doctors).
• The appeal to supplements in lieu of vaccines. No diet advice would be complete without a gratuitous attack on vaccines, right? The authors suggest that flu vaccines (for example) only provide immunity for 2 months “and only for certain individuals.” Meanwhile, they assert that a combination of Echinacea, garlic, and vitamin C support the immune system to successfully fight of viruses. These claims are simply unproven and multiple studies have already found no benefit (over placebo) of these supplements at preventing and treating the common cold.
• Over-diagnosis. If you think that the world of medicine is predisposed to seeing disease where there is none, try the alternative medicine world. The authors assert that everything from zits, to rashes, to “brain fog” are potential signs of grave underlying immune compromise – caused by, you guessed it, dietary deficiencies.
• Over-supplementation. The authors argue that “supplementation is a necessity in our nutrient-robbed world.” However, new evidence doesn’t support supplementation for the general population, though it had beentraditionally felt that multi-vitamins might be valuable. In addition, new studies are finding that food sources are preferable to supplements for daily nutritional requirements (such as calcium) and that anti-oxidants such as vitamin E may do more harm than good.
• The “organic is more nutritious” argument. Although a recent systematic review of the scientific literature found no support for the notion that organic foods contain more nutrients than those grown with traditional methods, the authors attribute Americans’ supposed vitamin deficiencies to poor soil quality caused by non-organic farming methods.
• Nutrigenomics and DNA hype. The authors do not take a sufficiently skeptical view of the emerging field of nutrigenomics (whereby certain foods and supplements are recommended to individuals based on their genetic profiles). They even suggest that nutrigenomic testing is so much fun, it’s “almost like being part of a CSI television show.” Who cares if it’s no more accurate than fortune telling?

So what’s the half true part? Well, obesity is certainly a driver of many modern illnesses, and obesity is caused by (in no small part) nutritional choices. The authors cite statistics on the ravages of heart disease, high blood pressure, and diabetes on the U.S. population which are all quite true. (How this supports the “deficiency” argument is somewhat lost on me – because it would seem more logical that a possible excess of nutrients could be the “one true cause” of a lot of these diseases, but I digress).

There are real nutritional deficiencies that cause medical problems, such as iron-deficiency anemia, neural tube defects related to folic acid deficiency, vitamin D deficiency and rickets, and osteoporosis contributed to by low calcium levels. These conditions underscore the importance of healthy eating habits, but do not support the idea that the entire population is deficient in these nutrients. In fact, a large population study analyzed by the CDC, suggests that most Americans are not deficient in any major nutrient even with their current sub-optimal and obesogenic eating habits.

In general, fair-minded individuals will find Eat To Save Your Life to be yet another example of a half-true, hysteria-peddling, micro-nutrient-obsessed diet advice book. Ironically, the book’s title itself states the opposite of what we really need to be doing to reduce obesity-related diseases: stop eating (so much) to save our lives.

This book may be purchased (against my medical advice) at Amazon.com.

***

This post originally appeared at the Science Based Medicine blog.

Dr. Oz’s Silly Weight Loss Recommendations Lead To Fat TV Ratings

December 17th, 2012 by admin in Quackery Exposed
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Miracles are pretty rare events. Except on television’s “Dr. Oz Show,” where they appear with astonishing frequency. Oz of course doesn’t claim to raise the dead or part the Red Sea, but he does raise people’s hopes of parting with their flab. And he’s certainly not shy about flinging the word “miracle” about. But it seems miracles fade as quickly as they appear. Raspberry ketones, acai berries and African mango, once hyped as amazing “fat busters,” have already given way to newer wonders.

Granted, Dr. Oz, or more likely his producers, do not pull miracles out of an empty hat. They generally manage to toss in a smattering of stunted facts that they then nurture into some pretty tall tales. Like the ones about chlorogenic acid or Garcinia cambogia causing effortless weight loss. The former piqued the public’s interest when the great Oz introduced green coffee bean extract as the next diet sensation. Actually “chlorogenic acid” is not a single compound, but rather a family of closely related compounds found in green plants, which perhaps surprisingly, contain no chlorine atoms. The name derives from the Greek “chloro” for pale green and “genic” means “give rise to.” (The element chlorine is a pale green gas, hence its name.)

An “unprecedented” breakthrough, Dr, Oz curiously announced, apparently having forgotten all about his previous weight-control miracles. This time the “staggering” results originate from a study of green coffee bean extract by Dr. Joe Vinson, a respected chemist at the University of Scranton who has a long-standing interest in antioxidants, such as chlorogenic acid. Aware of the fact that chlorogenic acid had been shown to influence glucose and fat metabolism in mice, Vinson speculated that it might have some effect on humans as well. Since chlorogenic acid content is reduced by roasting, a green bean extracts was chosen for the study.

In cooperation with colleagues in India who had access to volunteers, Dr. Vinson designed a trial whereby overweight subjects were given, in random order, for periods of six weeks each, either a daily dose of 1,050 mg of green coffee bean extract, a lower dosage of 700 mg, or a placebo. Between each six-week phase there was a two-week “washout” period during which the participants took no supplements. There was no dietary intervention; the average daily calorie intake was about 2,400. Participants burned roughly 400 calories a day with exercise. On average there was a loss of about a third of a kilogram per week. Interesting, but hardly “staggering.” And there are caveats galore.

The study involved only eight men and eight women, which amounts to a statistically weak sample. Diet was self-reported, a notoriously unreliable method. The subjects were not really blinded since the high dose regimen involved three pills, the lower dose only two. A perusal of the results also shows some curious features. For example, in the group that took placebo for the first six weeks, there was an 8 kilogram weight loss during the placebo and washout phase, but almost no further loss during the high dose and low dose phases. By the time, though, that critics reacted to Oz’s glowing account, overweight people were already panting their way to the health food store to pick up some green coffee bean extract that might or might not contain the amount of chlorogenic acid declared on the label. As for Dr. Oz, he had already moved on to his next “revolutionary” product, Garcinia cambogia, unabashedly describing it as the “Holy Grail” of weight loss.

We were actually treated to the Grail in action. Sort of. Dr. Oz, with guest Dr. Julie Chen, performed a demonstration using a plastic contraption with a balloon inside that was supposed to represent the liver. A white liquid, supposedly a sugar solution, was poured in, causing the balloon, representing a fat cell, to swell. Then a valve was closed, and as more liquid was introduced, it went into a different chamber, marked “energy.” The message was that the valve represents Garcinia extract, which prevents the buildup of fat in fat cells. While playing with balloons and a plastic liver may make for entertaining television, it makes for pretty skimpy science.

Contrary to Dr. Oz’s introduction that “you are hearing it here first,” there is nothing new about Garcinia. There’s no breakthrough, no fresh research, no “revolutionary” discovery. In the weight control field, Garcinia cambogia is old hat. Extracts of the rind of this small pumpkin-shaped Asian fruit have long been used in “natural weight loss supplements” Why? Because in theory, they could have an effect.

The rind of the fruit, sometimes called a tamarind, is rich in hydroxycitric acid (HCA), a substance with biological activity that can be related to weight loss. Laboratory experiments indicate that HCA can interfere with an enzyme that plays a role in converting excess sugar into fat, as well as with enzymes that break down complex carbohydrates to simple sugars that are readily absorbed. Furthermore, there are suggestions that Garcinia extract stimulates serotonin release which can lead to appetite suppression.

Laboratory results that point toward possible weight loss don’t mean much until they are confirmed by proper human trials. And there have been some. Fifteen years ago a randomized trial involving 135 subjects who took either a placebo or a Garcinia extract equivalent to 1500 mg of HCA a day for three months, showed no difference in weight loss between the groups. A more recent trial involving 86 overweight people taking either two grams of extract or placebo for ten weeks echoed those results. In-between these two major studies there were several others, some of which did show a weight loss of about one kilogram over a couple of months, but these either had few subjects or lacked a control group. Basically, it is clear that if there is any weight loss attributed to Garcinia cambogia, it is virtually insignificant. But there may be something else attributed to the supplement, namely kidney problems. Although incidence is rare, even one is an excess when the chance of a benefit is so small. So Garcinia cambogia, like green coffee bean extract, can hardly be called a miracle. But it seems Dr. Oz puts his facts on a diet when it comes to fattening up his television ratings.

joe.schwarcz@mcgill.ca

Joe Schwarcz is director of McGill University’s Office for Science & Society (mcgill.ca/oss). He hosts The Dr. Joe Show on CJAD Radio 800 AM every Sunday from 3 to 4 p.m.

Patients Are Rejecting Valuable Treatment Based On False Information

August 19th, 2011 by Davis Liu, M.D. in News, Opinion
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Newsweek has a very provocative and yet incredibly too simplistic piece for the public and patients on its cover story – One Word Can Save Your Life: No! – New research shows how some common tests and procedures aren’t just expensive, but can do more harm than good.

The piece is actually well written and highlights facts that have been apparent for some time.  More intervention and treatment isn’t necessarily better.  Having a cardiac catheterization or open heart surgery for patients with stable heart disease and mild chest pain isn’t better than diet, exercise, and the prescription medication treatment.  PSA, the blood test previously suggested by many professional organizations, isn’t helpful to screen for prostate cancer, even though the value of the test was questioned years ago.  Antibiotics for sinus infection?  Usually not helpful.

Certainly doctors do bear part of the blame.  If patients are Read more »

*This blog post was originally published at Saving Money and Surviving the Healthcare Crisis*