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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.

Yet Another Reason Why Dr. Oz Cannot Be Trusted: False Claims About Red Palm Oil

June 3rd, 2013 by admin in Opinion, Quackery Exposed
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Dr. Oz is a powerful guy, blessed with a name that conjures up wizardry. He just unveils his latest “miracle,” which seems to happen on an almost daily basis, and people scamper off to the nearest the health food. Recently the great Oz anointed the oil extracted from the fruit of the palm tree that grows in Indonesia and Malaysia as a wonder product that can aid weight loss and reduce the risk of Alzheimer’s and heart disease. Introduced to this marvel by his a guest, a homeopath, Dr. Oz excitedly gushed about the beta carotene and “special form of vitamin E” found in “red palm oil.” A curious business. Tell me, does a Professor of Surgery at Columbia University with over 400 research publications under his belt really need advice on nutrition from a homeopath?

As is usually the case with Oz’s miracles, there is a seed of truth that then gets fertilized with lots of verbal manure until it grows into a tree that bears fruit dripping with unsubstantiated hype. For example, one study did show a reduction in the severity of cholesterol-induced atherosclerosis in rabbits fed high doses of red palm oil. This has little relevance for humans but magicians who pull rabbits out of hats may consider adding red palm oil to the diet of their little assistant. The red colour of the oil comes from beta-carotene, the same substance that contributes to the hue of carrots and many other fruits and vegetables. It is the body’s precursor for vitamin A, which makes it an important nutrient.

Unfortunately, in many areas of the developing world there is a shortage of both beta carotene and vitamin A in the diet leading to a high incidence of blindness, skin problems and even death. In such cases red palm oil would be useful, but of course there are numerous other ways to introduce beta-carotene into the diet including “golden rice” that has been genetically modified to provide the nutrient. Aside from remedying a vitamin A deficiency, there is not much evidence for increased intake of beta carotene outside of that contained in a balanced diet. There are suggestions that higher blood levels of beta carotene reduce the risk of breast cancer in high-risk women, but the beta-carotene levels may just be a marker for a better diet.

As far as the Alzheimer’s connection goes, Oz may have been referring to a study in which 74 seniors with mild dementia were compared with 158 healthy seniors. People with dementia had lower levels of beta-carotene and vitamin C in their blood. Again, this does not prove that the lower levels are responsible for the condition, they may just signal a diet that is poorer in fruits and vegetables. Tocotrienols, the “special form of vitamin E” Oz talked about, have shown some borderline effects in Alzheimer’s patients at doses way higher than found in red palm oil. There is no evidence for preventing the disease.

What about the claim that red palm oil causes loss of belly fat? That seems to come from a rat study in which a tocotrienol-rich fraction extracted from palm oil caused a reduction in fat deposits in the omentum, the tissue that surrounds organs. There was no evidence of abdominal fat reduction, and furthermore, the study involved putting the animals on an unnatural and unhealthy diet. But these are not the facts that the audience was treated to on the Dr. Oz Show.

What the eager viewers witnessed were three visually captivating but totally irrelevant demonstrations of the purported health benefits of red palm oil. First in line was a piece of apple that had turned brown because of “oxidation.” This could be prevented with a squirt of lemon juice, Oz explained. Then came the claim that red palm oil protects our brain the same way that lemon juice protects the apple. This is absurd. Vitamin C inactivates polyphenol oxidase, the enzyme that allows oxygen to react with polyphenols in the apple resulting in the browning. The human brain, however, bears no resemblance to an apple, except perhaps for the brains of those who think it does. Yes, oxidation is a process that goes on in the human body all the time and has been linked with aging but suggesting that beta-carotene because of its antioxidant effects protects the brain like lemon juice protects the apple is inane.

Just as zany was the next demo in which two pieces of plastic half-pipe representing arteries were shown with clumps of some white guck, supposedly deposits that lead to heart disease. Oz poured a gooey liquid, representing “bad fats” down one of the tubes, highlighting that it stuck to the goo. Then he proceeded to pour red palm oil down the other pipe and lo and behold, the deposits washed away. Totally meaningless and physiological nonsense. The homeopath then explained that saturated fats behave like thick molasses cruising through the cardiovascular system, but palm oil does not, despite being high in saturated fats. While saturated fats may lead to deposits, they do not do this by “thickening” the blood. Arterial deposits are the result of some very complex biochemistry and are not caused by “sludge” in the blood. Oz even exclaimed that this demo was indicative of how red palm oil reduces cholesterol in a month by 40%, better than drugs. A search of Pubmed reveals no such study.

The final demonstration involved Dr. Oz lighting a candle and a flare, without wearing safety glasses mind you. The message seemed to be that the body burns most fats slowly, but it burns red palm oil with great efficiency, preventing weight gain. Where does this come from? Possibly some confusion about medium chain triglycerides which are somewhat faster metabolized than other fats. But these are not found in palm oil. They are found in coconut oil and palm kernel oil. Oz and his homeopath expert were as confused about this as about the rest of red palm oil info they belched out.

Aside from scientists who took issue with the misleading information, animal rights groups also attacked Oz’ exhortations about the benefits of the oil claiming that it will lead to destroying larger stretches of the jungle, home to many wild creatures including the orangutan. They maintain that when the jungle is cleared every living creature is either captured or killed and adult orangutans are often shot on sight. A tragedy. Another tragedy is that Dr. Oz could be doing so much good if he just focused on real science, as he sometimes does, instead of drooling over the latest “miracle” as presented by some pseudo expert.

***

Joe Schwarcz, Ph.D., is the Director of McGill University’s Office for Science and Society and teaches a variety of courses in McGill’s Chemistry Department and in the Faculty of Medicine with emphasis on health issues, including aspects of “Alternative Medicine”.  He is well known for his informative and entertaining public lectures on topics ranging from the chemistry of love to the science of aging.  Using stage magic to make scientific points is one of his specialties.

Medical Pseudoscience Is A Big Moneymaker

September 26th, 2011 by Steve Novella, M.D. in Health Policy, Opinion
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It is an unfortunate truth that there is money in pseudoscience, particularly medical pseudoscience. Money both attracts charlatans and also funds their activities, which includes marketing pseudoscience and defending their claims from scientific scrutiny. In this way the game is rigged in favor of pseudoscience.

With0ut effective regulation, sites like ours are forced to play whack-a-mole with the medical pseudoscience du jour. The latest case in point is Titanium Ion Bands – which are just another version of the Power Balance bands that have been previously exposed as nonsense. The idea is that by wearing a small bracelet on one wrist you will experience improved athletic performance. This sounds impossible – because it is. But companies have successfully bamboozled enough of the public to rake in millions.

The marketing strategy is three-fold. First, Read more »

*This blog post was originally published at Science-Based Medicine*

Electrodermal Testing Is Tantamount To Fooling Patients With A Magic Eight Ball

July 11th, 2011 by Harriet Hall, M.D. in Quackery Exposed
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Remember the Magic Eight Ball toy? You could ask it a question and shake it and a random answer would float up into a window: yes, no, maybe, definitely, etc. There is even a website where you can ask an Eight Ball questions online.

I have been meaning to write about bogus electrodiagnostic machines for a long time. These devices supposedly diagnose diseases and/or energy imbalances, indicate which remedies will correct the problem(s), and sometimes even treat the imbalances by transmitting a balancing frequency to the patient. I knew they were bogus, but I had never really realized the full extent of the deception until I viewed a set of training videos recently sent to me by a correspondent. I had never realized how similar electrodermal testing was to the Magic Eight Ball. I was further amazed at how they managed to combine every kind of alternative medicine into one incoherent package and to bamboozle patients with an appalling display of pseudoscientific babble.

This will be a two-part series. In the first, I will describe what the machines and their operators do. In the second (next week), I will address the legal and regulatory issues.

The History of EAV Devices

The first electrodermal diagnostic device was invented in 1958 by Reinhold Voll, a German medical doctor and acupuncturist. Read more »

*This blog post was originally published at Science-Based Medicine*

About Scar Prevention And Treatment

December 27th, 2010 by John Di Saia, M.D. in Better Health Network, Health Tips, Opinion, Quackery Exposed
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I saw a Scarguard product on sale at a drugstore locally. The claims on the packaging were over the top as usual:

1. “Guards against new scars forming” – Difficult to prove.

2. “Flattens and shrinks old scars” – Not really.

3. “Scarguard is the #1 choice of plastic surgeons” – Really? Nobody asked me.

Scar treatment is pretty simple. Avoid wounding if you can. If you have plastic surgery, seek a skilled surgeon who will spend the time to do the best. After surgery avoid sunlight and smoking, and consider scar massage as directed by your surgeon. This “Scarguard” product is not going to make a bad scar much better unless it is applied early, and even then the results are debatable.

– John Di Saia, M.D.

*This blog post was originally published at Truth in Cosmetic Surgery*