Daniels and Vogel recently published an article entitled “Consent in osteopathy: A cross sectional survey of patients’ information and process preferences” (INTERNATIONAL JOURNAL OF OSTEOPATHIC MEDICINE 2012, 15:3, p.92-102). It addresses an important yet woefully under-researched area.
I find most laudable that two osteopaths conduct research into medical ethics; but the questions still are, does the article tell us anything worth knowing and is it sufficiently rigorous and critical? As the journal does not seem to be available on Medline, I cannot provide a link. I therefore take the liberty of quoting the most important bits from directly the abstract here.
Objective: To explore and describe patients’ preferences of consent procedures in a sample of UK osteopathic patients.
Methods: A cross sectional survey using a new questionnaire was performed incorporating paper and web-based versions of the instruments. 500 copies were made available, (n = 200) to patients attending the British School of Osteopathy (BSO) clinic, and (n = 300) for patients attending 30 randomly sampled osteopaths in practice. Quantitative data were analysed descriptively to assess patient preferences; non-parametric analyses were performed to test for preference difference between patients using demographic characteristics.
Results: 124 completed questionnaires were returned from the BSO sample representing a 41% response rate. None were received from patients attending practices outside of the BSO clinic. The majority (98%) of patient respondents thought that having information about rare yet potentially severe risks of treatment was important. Patients’ preferred to have this information presented during the initial consultation (72%); communication method favoured was verbal (90%). 99% would like the opportunity to ask questions about risks, and all respondents (100%) consider being informed about their current diagnosis as important.
Conclusion: Patients endorse the importance of information exchange as part of the consent process. Verbal communication is very important and is the favoured method for both receiving information and giving consent. Further research is required to test the validity of these results in practice samples
The 0% response-rate in patients from non-BSO practices is, of course, remarkable and not without irony. In my view, it highlights better than anything else the fact that informed consent rarely appears on the osteopathic radar screen. In a way, this increases the praise we should give the two authors for tackling the issue.
The central question of the survey is whether patients want to know about the risks of osteopathy. This is more than a little bizarre: informed consent is not an option, it is a legal, moral and ethical obligation. It seems therefore odd to ask the question “do you want to learn about the risks which you are about to be exposed to?”
Even odder is, I think, the second question “when do you want to receive this information?” It goes without saying that informed consent has to happen before the intervention! This is what, common sense tells us, the law dictates and ethical codes prescribe.
There is general agreement amongst health care professionals and ethicist that verbal consent does suffice in most therapeutic situations, that patients must have the opportunity to ask questions, and that informed consent also extends to diagnostic issues. So, the questions referring to these issues are also a bit strange or naive, in my view.
The article might be revealing mostly by what it does not address rather than by what it tells us. It would be really valuable to know the percentage of osteopaths who abide by the legal, moral and ethical imperative of informed consent in their daily practice. To the best of my knowledge, this information is not available [if anyone has such information, please let me know and provide the reference]. Assuming that it is similar to the percentage of UK chiropractors who obtain informed consent, it might be seriously wanting: only 45% of them routinely obtain informed consent from their patients.
Another issue that, in my view, would be relevant to clarify is the nature of the information provided by osteopaths to patients, other than that of serious risks associated with spinal manipulation/mobilisation. Do they tell their patients about the evidence suggesting that osteopathy does (not) work for the condition at hand? Do they elaborate on non-osteopathic treatments for that disease? I fear that the answers to these questions might well be negative.
Imagine a patient being told that there is no good evidence for effectiveness of osteopathy, that the possibility of some harm exists, and that other interventions might actually do more good than harm than what the osteopath has to offer. How likely is it that this patient would agree to receiving osteopathic treatment?
For most alternative practitioners, including osteopaths, informed consent and most other important ethical issues have so far remained highly uncomfortable areas. This may have a good and simple reason: they have the potential to become real and serious threats to their current practice and business. I suspect this is why there is so very little awareness of and research into the ethics of alternative medicine: “best not to wake sleeping lions”, seems to be the general attitude.
The survey by Daniels and Vogel, even though it touches upon an important topic, avoids the truly pertinent questions. It therefore looks to me a bit like a fig leaf shamefully hiding an area of potential embarrassment.
And where do we go from here? I predict that the current strategy of alternative practitioners to ignore and violate medical ethics as much as possible will not be tolerated for much longer. Double standards in health care cannot and should not survive. The sooner we begin addressing some of these uncomfortable questions with rigorous research, the better – perhaps not for the practitioner but certainly for the patient.
Vaccinations are unquestionably amongst the biggest achievements in the history of medicine. They have prevented billions of diseases and saved millions of lives. Despite all this, there has been an irritatingly vocal movement protesting against immunizations and thus jeopardising the progress made. Kata summarized the notions and tactics of these activists and identified the following ‘common anti-vaccination tropes‘ from searching relevant sites on the internet:
1 I am not anti-vaccine, I am pro-safe vaccine.
2 Vaccines are toxic.
3 Vaccines should be 100% safe.
4 You cannot prove that vaccines are safe.
5 Vaccines did not save us.
6 Vaccines are not natural.
7 I am an expert in my own child.
8 Galileo was persecuted too.
9 Science has been wrong before.
10 So many people simply cannot be wrong.
11 You must be in the pocket of BIG PHARMA.
12 I do not believe that the problems after vaccination occur coincidentally.
And what has this to do with alternative medicine, you may well ask?
In my experience, many of the arguments resonate with those of alternative medicine enthusiasts. Moreover, there is a mountain of evidence to show that many practitioners of alternative medicine are an established and important part of the anti-vax movement; in particular, homeopaths, chiropractors, naturopaths and practitioners of anthroposophic medicine are implicated.
The literature on this topic is vast, so I am spoilt for choice in providing an example. The one that I have selected is by Kate Birch, a mother who apparently found homeopathy so effective for her children that she decided to become a homeopath. Her book “Vaccine Free. Prevention & treatment of infectious contagious disease with homeopathy” provides details about the “homeopathic prevention and treatment” of the following diseases:
Rocky Mountain spotted fever
Herpes simplex type 1 and 2
Hepatitis A, B, and C
While copying this list from her book, I became so angry that I was about to write something that I might later regret. It is therefore better to end this post abruptly. I leave it to my readers to comment.
On the last day of the year, is time to contemplate the achievements and failures of the past 12 months and think about the future. For me, it is also the moment to once again place my tongue in my cheek, empathise with my opponents and think of what they might hope for in the coming year.
Here is a brief yet somewhat ambitious expose of what I came up with: the charlatan’s wish list for 2013.
1 Let the Daily Mail and similar publications continue to promote uncritical thinking and bogus claims for alternative medicine.
2 Make sure that politicians remain blissfully ignorant of all matters related to science.
3 Let the anecdote continue to reign over evidence, for instance, in the popular press.
4 Regulate alternative practitioners such that they benefit from the added status without any obligation to abide by the generally accepted rules of evidence-based practice.
5 Prevent the closure of more homeopathic hospitals.
6 Ensure that the public continues to be mislead about nonsensical scams such as “integrated medicine”.
7 Increase the influence of Prince Charles in the realm of health care.
8 Give Royal status to the ‘College of Medicine’.
9 Appoint Dr Michael Dixon, chair of the ‘NHS-Alliance’ and the above-named “college”, as advisor to the government.
10 Introduce more post-modern thinking into health care; after all, there is more than one way of knowing!
11 Defame all those terrible sceptics who always doubt our claims.
12 Cherish double standards in medicine; they are essential for our survival!
13 Make sure researchers of alternative medicine use science not for testing but for proving the value of alternative therapies.
14 Continue to allow promotion of alternative medicine to masquerade as research.
15 Ensure that all our celebrity clients tell every journalist how young they look thanks to alternative medicine.
16 Let ‘Duchy’s Original detox Tincture’ become a financial success – Charles needs the added income for promoting quackery.
17 Open more woo-institutes in academia to spread the gospel of belief-based medicine.
18 Prevent anyone from finding out that many of us break even the most fundamental rules of medical ethics in our daily practice.
I am aware that the list is probably not nearly complete, and I invite everyone to add items of importance. Happy New Year!
In these austere and difficult times, it must be my duty, I think, to alert my fellow citizens to a possible source of additional income which almost anyone can plug into: become a charlatan, and chances are that your economic hardship is a memory from the past. To achieve this aim, I [with my tongue firmly lodged in my cheek] suggest a fairly straight forward step by step approach.
1. Find an attractive therapy and give it a fantastic name
Did I just say “straight forward”? Well, the first step isn’t that easy, after all. Most of the really loony ideas turn out to be taken: ear candles, homeopathy, aura massage, energy healing, urine-therapy, chiropractic etc. As a true charlatan, you want your very own quackery. So you will have to think of a new concept.
Something truly ‘far out’ would be ideal, like claiming the ear is a map of the human body which allows you to treat all diseases by doing something odd on specific areas of the ear – oops, this territory is already occupied by the ear acupuncture brigade. How about postulating that you have super-natural powers which enable you to send ‘healing energy’ into patients’ bodies so that they can repair themselves? No good either: Reiki-healers might accuse you of plagiarism.
But you get the gist, I am sure, and will be able to invent something. When you do, give it a memorable name, the name can make or break your new venture.
2. Invent a fascinating history
Having identified your treatment and a fantastic name for it, you now need a good story to explain how it all came about. This task is not all that tough and might even turn out to be fun; you could think of something touching like you cured your moribund little sister at the age of 6 with your intervention, or you received the inspiration in your dreams from an old aunt who had just died, or perhaps you want to create some religious connection [have you ever visited Lourdes?]. There are no limits to your imagination; just make sure the story is gripping – one day, they might make a movie of it.
3. Add a dash of pseudo-science
Like it or not, but we live in an age where we cannot entirely exclude science from our considerations. At the very minimum, I recommend a little smattering of sciency terminology. As you don’t want to be found out, select something that only few experts understand; quantum physics, entanglement, chaos-theory and Nano-technology are all excellent options.
It might also look more convincing to hint at the notion that top scientists adore your concepts, or that whole teams from universities in distant places are working on the underlying mechanisms, or that the Nobel committee has recently been alerted etc. If at all possible, add a bit of high tech to your new invention; some shiny new apparatus with flashing lights and digital displays might be just the ticket. The apparatus can be otherwise empty – as long as it looks impressive, all is fine.
4. Do not forget a dose of ancient wisdom
With all this science – sorry, pseudo-science – you must not forget to remain firmly grounded in tradition. Your treatment ought to be based on ancient wisdom which you have rediscovered, modified and perfected. I recommend mentioning that some of the oldest cultures of the planet have already been aware of the main pillars on which your invention today proudly stands. Anything that is that old has stood the test of time which is to say, your treatment is both effective and safe.
5. Claim to have a panacea
To maximise your income, you want to have as many customers as possible. It would therefore be unwise to focus your endeavours on just one or two conditions. Commercially, it is much better to affirm in no uncertain terms that your treatment is a cure for everything, a panacea. Do not worry about the implausibility of such a claim. In the realm of quackery, it is perfectly acceptable, even common behaviour to be outlandish.
6. Deal with the ‘evidence-problem’ and the nasty sceptics
It is depressing, I know, but even the most exceptionally gifted charlatan is bound to attract doubters. Sceptics will sooner or later ask you for evidence; in fact, they are obsessed by it. But do not panic – this is by no means as threatening as it appears. The obvious solution is to provide testimonial after testimonial.
You need a website where satisfied customers report impressive stories how your treatment saved their lives. In case you do not know such customers, invent them; in the realm of quackery, there is a time-honoured tradition of writing your own testimonials. Nobody will be able to tell!
7. Demonstrate that you master the fine art of cheating with statistics
Some of the sceptics might not be impressed, and when they start criticising your ‘evidence’, you might need to go the extra mile. Providing statistics is a very good way of keeping them at bay, at least for a while. The general consensus amongst charlatans is that about 70% of their patients experience remarkable benefit from whatever placebo they throw at them. So, my advice is to do a little better and cite a case series of at least 5000 patients of whom 76.5 % showed significant improvements.
What? You don’t have such case series? Don’t be daft, be inventive!
8. Score points with Big Pharma
You must be aware who your (future) customers are (will be): they are affluent, had a decent education (evidently without much success), and are middle-aged, gullible and deeply alternative. Think of Prince Charles! Once you have empathised with this mind-set, it is obvious that you can profitably plug into the persecution complex which haunts these people.
An easy way of achieving this is to claim that Big Pharma has got wind of your innovation, is positively frightened of losing millions, and is thus doing all they can to supress it. Not only will this give you street cred with the lunatic fringe of society, it also provides a perfect explanation why your ground-breaking discovery has not been published it the top journals of medicine: the editors are all in the pocket of Big Pharma, of course.
9. Ask for money, much money
I have left the most important bit for the end; remember: your aim is to get rich! So, charge high fees, even extravagantly high ones. If your treatment is a product that you can sell (e.g. via the internet, to escape the regulators), sell it dearly; if it is a hands-on therapy, charge heavy consultation fees and claim exclusivity; if it is a teachable technique, start training other therapists at high fees and ask a franchise-cut of their future earnings.
Over-charging is your best chance of getting famous – or have you ever heard of a charlatan famous for being reasonably priced? It will also get rid of the riff-raff you don’t want to see in your surgery. Poor people might be even ill! No, you don’t want them; you want the ‘worried rich and well’ who can afford to see a real doctor when things should go wrong. But most importantly, high fees will do a lot of good to your bank account.
Now you are all set. However, to prevent you from stumbling at the first hurdle, here are some handy answers to the questions you inevitably will receive from sceptics, this nasty breed that is never happy. The answers are not designed to convince them but, if voiced in public, they will ensure that the general opinion is on your side – and that’s what is paramount in the realm of quackery.
Q: Your treatment can cause considerable harm; do you find that responsible?
A: Harm? Do you know what you are talking about? Obviously not! Every year, hundreds of thousands die because of the medicine they received from mainstream doctors. This is what I call harm!
Q: Experts say that your treatment is not biologically plausible, what is your response?
A: There are many things science does not yet understand and many things that it will never understand. In any case, there are other ways of knowing, and science is but one of them.
Q: Where are the controlled trials to back up your claim?
A: Clinical trials are of very limited value; they are far too small, frequently biased and never depict the real life situation. This is why many experts now argue for better ways of showing the value of medical interventions.
Q: Professor Ernst recently said that your therapy is unproven, is that true?
A: This man cannot be trusted; he is in the pocket of the pharmaceutical industry! He would say that, wouldn’t he?
Anyway, did you know that only 15% of conventional therapies actually are evidence-based?
Q: Why is your treatment so expensive?
A: Years of training, a full research programme, constant audits, compliance with regulations, and a large team of co-workers – do you think that all of this comes free? Personally, I would treat all my patients for free (and often do so) but I have responsibilities to others, you know.
Let me briefly pick up the issue about ad hominem attacks mentioned at the end of my last post.
One of the most striking feature of the debates about alternative medicine is, in my experience, the fact that, whenever the defenders of the indefensible ran out of rational arguments, personal attacks are rarely far. Personal or ad hominem attacks are fallacious arguments directly directed at a named individual which serve as substitutes for that individual’s arguments. In football terminology, they play the player instead of the ball.
After many years of being at the receiving end of this phenomenon, I have grown to be amused by it, not just amused, I have slowly started to appreciate it. Strange? Let me explain.
Initially, I have to admit, I was annoyed, sometimes livid when someone hurled a personal attack in my direction. At one stage, I even investigated whether my university did not have the obligation to legally protect me in such situations. Predictably, the answer was negative.
Later I considered on one or two occasions taking legal action myself. However, after just a minimum of reflection, I dismissed the idea: it is bad enough that the British Chiropractic Association sued my friend and co-author Simon Singh for libel, but under no circumstances did I want to display a similarly deplorable behaviour.
Eventually, I realised that an ad hominem attack often is an important signal indicating that the attacker is wrong, very wrong indeed. It is nothing else than an open admission by “the other side” that they have no more reasonable arguments, that they are resorting to unreasonable notions, and that they have lost not just the plot but also the debate. In other words, being personally attacked in this way is a compliment and an unfailing sign of victory – and, if that is so, we should be proud of every single ad hominem attack we get after a well-reasoned debate.
Even on this relatively young blog, we have already seen signs of such victories; most notably a chiropractor recently conceded defeat after a perfectly reasonable debate on the safety of spinal manipulation by stating that “Ernst is an infamous medical demagogue who speaks nonsense“. Yet this little outburst of chiropractic self-humiliation is nothing compared to plethora of similar statements elsewhere on the internet. The following list is the result of just ~10 minutes of searching; I took the liberty of copying a short quote from each site but enthusiasts will find much more revealing stuff, I’m sure.
“…whether he [Ernst] has only written or also read them [the reviews he has published], is a matter of dispute between experts…”
“…he’s really just another dull academic who knows nothing about it. The fact that someone decided he could have a title that makes it sound like he’s knowledgable [sic] is irrelevant, he remains a nobody in the field of complementary therapy, his own university don’t even seem to like him, just about everything he says is negative and no ordinary member of the public I’ve ever mentioned him to has heard of him at all, so although he’s beloved by a few hacks and a small platoon of cynics, the rest of the world could not give a toss.”
“Edzard Ernst Exposed as a Fraud and a Liar”
“Edzard Ernst, Britains self proclaimed “first Professor of Complementary Medicine” is finding himself with a lack of funding and his unit is facing closure.
He is blaming his clash with Prince Charles, but why Professor Ernst thinks anyone wants to fund someone who claims to be a professor of CAM, yet spends all his time debunking CAM we will never know. Its a rather strange scenario we feel!”
“From time to time you may see news reports about “an expert” named Edzard Ernst who regularly offers commentary about the value of homeopathic medicine. Ignore any such references he makes on the subject. He has never received even an introductory education on the subject of homeopathy”
“Why should anyone believe what Professor Edzard Ernst says, after he put his name to a BBC programme, he now describes as “deception”.”
“EDZARD ERNST and the Evil Empire at Exeter”
“Edzard Ernst, is not a credible source of information about the effectiveness of homeopathy”
“Prof Edzard Ernst (family motto: ‘I have not come to praise alternative medicine, I have come to bury it’) who has hardly said a good word for alternative medicine in all the years he has held the recently-created Complementary Medicine chair at Exter [sic]University. ”
“the pharma-friendly gold standard that Ernst and his colleagues seem to worship”
“Edzard Ernst of the Medical School at the University of Exeter wrote his infamous 2010 study from England, “Deaths After Chiropractic: A Review Of Published Cases,” that once again raised the level of fear over chiropractic care when he noted that “Twenty-six fatalities were published since 1934 in 23 articles”
It is hard to deny that these statements are amusing. But by far my favourite personal attacker is a German chap called Claus Fritzsche. He runs a website which, at one stage, seemed almost entirely dedicated to telling lies about me; and, what is best of all, he even took money for these efforts from several homeopathic manufacturers. Surely, apart from perhaps the Nobel Prize, this must be the nicest recognition, the sweetest feast of victory and greatest compliment any scientist might ever wish for.
So, ad hominem attackers of all ages, types, nationalities and persuasions, please keep them coming. I am unlikely to sue for libel; on the contrary, I will celebrate them for what they truly are: they are compliments for me, victories for reason and admissions of defeat for you.
Craniosacral therapy (CST), which, confusingly, is sometimes also called ‘cranial osteopathy’, was invented less than half a century ago by an osteopath. He thought that the spinal fluid is pulsating, the cranial bones are sufficiently movable to enable a therapist feel this pulse from the outside, and that it is possible to influence this process with very gentle manual manipulations which, in turn, would restore health in sick individuals. According to the inventor, the CST-practitioner uses his or her own hands to evaluate the craniosacral system by gently feeling various locations of the body to test for the ease of motion and rhythm of the fluid pulsing around the brain and spinal cord. Soft-touch techniques are then used to release restrictions in any tissues influencing the craniosacral system.
But how does CST work? Let’s ask a practitioner who surely must know best:
When a self-development issue is linked to the illness, it is enough for that issue to be acknowledged by the client (without any further discussion unless the client desires it) for the body to release the memory of that issue – sensed by the therapist as tightness, tension, inertia within the body’s systems – so that the healing can proceed.
Several treatment sessions may still be needed, especially if the condition is a long lasting one. Our bodies’ self healing mechanisms rely on a combination of the various fluid systems of the body (blood and lymph flow and the fluid nature of the cells making up all the organs and systems within our bodies) and the body’s energy fields. Our hearts generate their own electrical signal independently of the control of our brains. Such signals travel around the body through the blood and other fluid systems. Blood is an excellent conductor of electricity and, when electricity flows through a conductor, magnetic fields are created. It is with these fields that the craniosacral therapist works.
These same fields store the memory of the events of our life – rather like the hard disk on a computer – but these memories can only be accessed when the underlying Body intelligence ‘decides’ it is needed as part of the healing process. There is absolutely no danger, therefore, of more being revealed than is strictly necessary to encourage the client back onto their self development route and to enable healing to take place.
To many desperate patients or distressed parents of ill children – CST is often advocated for children, particularly those suffering from cerebral palsy – this sort of lingo might sound impressive; to anyone understanding a bit of physiology, anatomy etc. it looks like pure nonsense. CST has therefore been considered by most independent experts to be on the lunatic fringe of alternative medicine.
Of course, this does not stop proponents to make and publicise big therapeutic claims for CST; it would be quite difficult to think of a condition that some CST-practitioner does not claim to cure or alleviate. One UK organisation boldly states that any symptom a patient may present with will improve in the hands of one of their members; in the eyes of its proponents, CST clearly is a panacea.
But, let’s be fair, the fact that it is implausible does not necessarily mean that CST is useless. The theory might be barmy and wrong, yet the treatment might still be effective via a different, as yet unknown mechanism. What we need to decide is evidence from clinical trials.
Recently, I have evaluated the findings from all randomised clinical trials of CST. I was pleasantly surprised to find that 6 such trials had been published, one would not normally expect so many studies of something that seems so utterly implausible. Far less impressive was the fact that the quality of the studies was, with the exception of one trial, deplorably poor.
The conditions treated in the trials were diverse: cerebral palsy, migraine, fibromyalgia and infant colic. All the badly-flawed studies reported positive results. The only rigorous trial was the one with children suffering from cerebral palsy – and here the findings were squarely negative. The conlusion of my review was blunt and straight forward: “the notion that CST is associated with more than non-specific effects is not based on evidence from rigorous randomised clinical trials“. This is a polite and scientific way of saying that CST is bogus.
Why should this matter? CST is popular, particularly for children. It is a very gentle technique, and some might argue that no harm [apart from the cost] can be done; on the contrary, the gentle touch might even calm over-excited children and could thus be helpful. Who then cares that it has no specific therapeutic effects?
Few people would argue against the potential benefits of gentle touch or other non-specific effects. But we should realise that, for achieving them, we do not need CST or other placebo-treatments. An effective therapy that is given with compassion and empathy will do the same trick; and, in addition, it will also generate specific therapeutic effects.
What follows is simple: administering CST or other bogus treatments [by this, I mean a treatment for which claims are being made that are not supported by sound evidence] means preventing the patient from profiting from the most important element of any good treatment. In such cases, patients will not be treated adequately which can not just cost money but, in extreme cases, also lives.
In a nutshell: 1) ineffective therapies, such as CST, may seem harmless but, through their ineffectiveness, they constitute a serious threat to our health; 2) bogus treatments become bogus through the false claims which are being made for them; 3) seriously flawed studies can be worse than none at all: they generate false positive results and send us straight up the garden path.
Guest post by Louise Lubetkin
A while ago this sardonic little vignette, titled Medicine Through the Ages, was doing the rounds on the Internet:
2000 B.C. – Here, eat this root.
1000 A.D. – That root is pagan. Here, say this prayer.
1750 A.D. – That prayer is superstition. Here, drink this potion.
1900 A.D. – That potion is snake oil. Here, swallow this pill.
1985 A.D. – That pill is ineffective. Here, take this antibiotic.
2000 A.D. – That antibiotic is unnatural. Here, eat this root.
We seem to have come full circle. The idea of health as a personal goal, something that can be achieved by taking nutritional supplements such as herbal preparations, vitamins and minerals, is a fundamental tenet of alternative medicine. Consequently the rise of alternative medicine has been accompanied by a parallel rise in the use of dietary supplements.
Most people assume that dietary supplements, like pharmaceuticals, are thoroughly tested before being allowed onto the market, and that in any case because they are “natural” they are ipso facto safe.
Neither assumption is correct.
First of all, it is a great mistake to assume that all “natural” substances are harmless and therefore fit for consumption. (Fugu anyone? Perhaps with some sautéed Amanita mushrooms?) Secondly, unlike pharmaceuticals, which must undergo protracted pre-market testing for safety and efficacy, dietary supplements need not undergo even rudimentary testing before being sold over the counter to the public.
Supplement usage is at an all-time high. Currently, almost 50 percent of us regularly take supplements. The older you are, the more likely you are to take them: usage climbs to 70 percent amongst people 70 years and older. Similarly, the more formal education you have had, and the higher your income level, the more likely you are to be a regular consumer of dietary supplements.
Our collective enthusiasm for taking supplements has undoubtedly done considerably more for the health of the supplement industry than it has for that of the public. There is mounting research evidence to suggest that taking dietary supplements may neither be as safe nor beneficial to health as has previously been assumed (more on this in another post). Nevertheless, physicians seem to be just as vulnerable as the rest of us to the blandishments of the supplement industry. According to one study published in the Journal of Nutrition, 75 percent of dermatologists, 73 percent of orthopedists and 57 percent of cardiologists reported personally using dietary supplements. An earlier study by the same research group found that a staggering 79 percent of physicians and 82 percent of nurses reported recommending dietary supplements to their patients. Of course the fact that supplements come with a personal recommendation by a physician only serves to reinforce the public’s ill-founded presumption of safety.
The manufacture and sale of supplements is a hugely profitable business, generating more than $25 billion in annual sales and contributing an estimated $60 billion to the US economy. While most other industries have languished during the current economic downturn, the supplement industry has grown steadily: overall, between 2008 and 2012, sales of supplements rose by 31.7 percent.
(Ironically, the huge popularity of these so-called “natural” health products has not escaped the notice of agribusiness and pharmaceutical giants such as Kellogg’s, Pfizer, Monsanto and others, all of which have now begun manufacturing and marketing nutritional supplements of their own.)
None of this would have been possible had it not been for the 1994 enactment by the US Congress of the Dietary Supplement Health and Education Act (DSHEA), an extraordinarily ill-conceived piece of legislation that drastically weakened the FDA’s regulatory control over vitamins, minerals, herbal, botanical and other “traditional” medical products. Prior to DSHEA, these products were classified as drugs and were therefore subject to FDA regulation. By reclassifying them as foods rather than drugs DSHEA effectively removed dietary supplements from FDA regulatory oversight. As a result, supplement manufacturers became exempt from any obligation to perform pre-market testing for purity, safety or effectiveness, and it became infinitely harder for the FDA to detect unsafe products and quickly remove them from the market.
While the FDA does have the authority to insist that manufacturers refrain from making unsubstantiated health claims, it no longer has the power to mandate removal of unsafe products from the market without first clearing the almost insurmountable legal hurdle of proving significant risk. In other words, DSHEA inverts the responsibility for ensuring safety. Before the FDA can act, consumers must first be harmed sufficiently seriously, and in sufficient numbers, to trigger an investigation.
In one fell legislative swoop, DSHEA dished up a profit bonanza to the supplement industry while simultaneously robbing the public of any meaningful protection. Thus disencumbered of all but token regulation, the dietary supplement industry quickly burgeoned. In 1994, when DSHEA was enacted, there were just 4,000 dietary supplements on the market. Today there are more than 75,000.
The brave new world spawned by DSHEA is well exemplified by the ephedra case. Herbal weight loss supplements containing the plant alkaloids ephedra and ephedrine were linked to a string of over 150 deaths and countless other serious adverse events. Metabolife, the manufacturer of the supplement, received 15,000 complaints of adverse events – including deaths – related to the product, yet was under no obligation to alert the FDA, and (not surprisingly) chose not to do so.
It took a full 10 years of intense legal fighting for the FDA to succeed in getting ephedra-containing supplements removed from the market. Undeterred, powerful industry lobbying groups and vociferous opponents of regulation mounted a successful appeal challenging the legality of the FDA ban, and ephedra supplements once again went on sale in several states. The ruling against FDA was eventually overturned on appeal and the ephedra ban was upheld, but the cost, difficulty and duration of the legal process of restricting access to this dangerous “natural” supplement was staggering. Yet even now, despite the FDA’s hard-won ban on ephedra, it is perfectly legal to buy ephedrine hydrochloride – an extract of ephedra – over the counter in the US, where it is marketed for sale without prescription as a bronchodilator and nasal decongestant. The only restriction on its sale is that it must be presented in pill form with dosage not exceeding 8mg, and the label cannot promote it as a weight loss aid – a restriction which can be sidestepped with the greatest of ease, as this website, with the in-your-face domain name ephedrinediet.org, vividly demonstrates.
Perhaps not surprisingly, the ephedra case is the only time the FDA has attempted to force the removal of a dangerous supplement from the market. Hamstrung by DSHEA, the FDA can do little more than exert its limited authority over the wording on supplement labels to ensure that manufacturers make no explicit claims that their products may be used prevent, cure or treat a specific disease. However, the lack of seriousness with which an increasingly confident supplement industry takes the FDA and its semantic policing powers is well illustrated by the following statement which appears in a recent report published by the Natural Products Foundation, an industry umbrella and lobbying group:
Healthy consumers use supplements to decrease their risk of heart disease, boost their immune systems, prevent vision loss, build strong bones, or prevent birth defects. Less healthy or ill consumers turn to supplements as an alternative to traditional medical treatments, to either complement prescription drugs they may be taking or substitute supplements for prescription drugs they either cannot afford or do not trust.
There are encouraging signs that concern about the dangers posed by an largely unregulated supplement industry may at last be growing, although industry and grass-roots opposition to attempts to repeal DSHEA have been well organized, well funded and vociferous. Even so, in 2007, largely as a result of public unease over the FDA’s protracted struggle to ban ephedra, DSHEA was amended to make reporting of serious adverse events such as death, life-threatening emergencies, inpatient hospitalizations or significant, persistent incapacities, mandatory. As a result of this amendment, in the first 9 months of 2008 alone, the FDA received almost 600 reports of serious adverse events arising from the use of dietary supplements. Moreover, the FDA believes that adverse events are being seriously under-reported, and that the annual number of supplement-related adverse events in the US is close to 50,000.
Perhaps it will take another ephedra disaster to make us rethink DSHEA, take the handcuffs off the FDA and begin looking more critically at the notion that dietary supplements are intrinsically beneficial and harmless.
In the meantime, here’s the 2013 addendum to Medicine Through the Ages:
2000 A.D. – That antibiotic is unnatural. Here, eat this root.
2013 A.D. – Has that root been assayed for adulterants, standardized for potency and purity? Has that root been approved by the FDA following clinical trials to establish dosage, efficacy and safety? Is the use of that root use evidence-based? Is it safe to take that root concurrently with other roots? Are there any contraindications? My diet already contains roots; will taking more be too much?
There are few subjects in the area of alternative medicine which are more deceptive than the now fashionable topic of “integrated medicine” (or integrative medicine, healthcare etc.). According to its proponents, integrated medicine (IM) is based mainly on two concepts. The first is that of “whole person care”, and the second is often called “the best of both worlds”. Attractive concepts, one might think – why then do I find IM superfluous, deeply misguided and plainly wrong?
Whole patient care or holism
Integrated healthcare practitioners, we are being told, do not just treat the physical complaints of a patient but look after the whole individual: body, mind and soul. On the surface, this approach seems most laudable. Yet a closer look reveals major problems.
The truth is that all good medicine is, was, and always will be holistic: today’s GPs, for instance, should care for their patients as whole individuals dealing the best they can with physical problems as well as social and spiritual issues. I said “should” because many doctors seem to neglect the holistic aspect of care. If that is so, they are, by definition, not good doctors. And, if the deficit is wide-spread, we should reform conventional healthcare. But delegating holism to IM-practitioners would be tantamount to abandoning an essential element of good healthcare; it would be a serious disservice to today’s patients and a detriment to the healthcare of tomorrow.
It follows that the promotion of IM under the banner of holism is utter nonsense. Either it is superfluous because it misleads patients into believing holism is an exclusive feature of IM, while, in fact, it is a hallmark of any good healthcare. Or, if holism is neglected or absent in a particular branch of conventional medicine, it detracts us from the important task to remedy this deficit. We simply must not allow a core value of medicine to be highjacked.
The best of both worlds
The second concept of IM is often described as “the best of both worlds”. Proponents of IM claim to use the “best” of the world of alternative medicine and combine it with the “best” of conventional healthcare. Again, this concept looks commendable at first glance but, at closer inspection, serious doubts emerge.
They hinge, in my view, on the use of the term “best”. We have to ask, what does “best” stand for in the context of healthcare? Surely it cannot mean the most popular or fashionable – and certainly “best” is not by decree of HRH Prince Charles. Best can only signify “the most effective” or more precisely “being associated with the most convincingly positive risk/benefit balance”.
If we understand “the best of both worlds” in this way, the concept becomes synonymous with the concept of evidence-based medicine (EBM) which represents the currently accepted thinking in healthcare. According to the principles of EBM, treatments must be shown to be safe as well as effective. When treating their patients, doctors should, according to EBM-principles, combine the best external evidence with their own experience as well as with the preferences of their patients.
If “the best of both worlds” is synonymous with EBM, we clearly don’t need this confusing duplicity of concepts in the first place; it would only distract from the auspicious efforts of EBM to continuously improve healthcare. In other words, the second axiom of IM is as nonsensical as the first.
The practice of integrated medicine
So, on the basis of these somewhat theoretical considerations, IM is a superfluous, misleading and counterproductive distraction. But the most powerful argument against IM is really an entirely practical one: namely the nonsensical, bogus and dangerous things that are happening every day in its name and under its banner.
If we look around us, go on the internet, read the relevant literature, or walk into an IM clinic in our neighbourhood, we are sure to find that behind all these politically correct slogans of holism and” best of all worlds” there is the coal face of pure quackery.Perhaps you don’t believe me, so go and look for yourself. I promise you will discover any unproven and disproven therapy that you can think of, anything from crystal healing to Reiki, and from homeopathy to urine-therapy.
What follows is depressingly simple: IM is a front of half-baked concepts behind which boundless quackery and bogus treatments are being promoted to unsuspecting consumers.
“Don’t take this therapy lightly. Multiple sclerosis, colitis, lupus, rheumatoid arthritis, cancer, hepatitis, hyperactivity, pancreatic insufficiency, psoriasis, eczema, diabetes, herpes, mononucleosis, adrenal failure, allergies and so many other ailments have been relieved through use of this therapy. After you overcome your initial gag response (I know I had one), you will realize that something big is going on, and if you are searching for health, this is an area to investigate. There are numerous reports and double blind studies which go back to the turn of the century supporting the efficacy of using urine for health”. This quote refers to a treatment that I, and probably most readers of this blog, find truly amazing – even in the realm of alternative medicine, we do not often come across a therapy as bizarre as this one: urine therapy.
Urine therapy enthusiasts claim that your own urine administered either externally, internally or both, has a long history of use, that most medical cultures have usefully employed it, that many VIPs swear by it, that it can cure almost all diseases and that it can save lives. What was new to me is the claim that it is supported by numerous double-blind studies.
Such trials would, of course, be entirely feasible; all you need to do is to give one group of patients the experimental treatment, while the other takes a placebo. Recruitment might be a bit of a problem, and the ethics committee might raise one or two eyebrows but, in theory, it certainly seems doable. So where are the “numerous” studies?
A quick, rough and ready Medline-Search found several unfortunate authors with the last name of “URINE”, yet no clinical trials of urine therapy emerged. A little more time-consuming search through my books on alternative medicine revealed nothing that remotely resembled evidence. At this point, I arrived at the conclusion that the clinical trials are either non-existent or extremely well hidden. Further searches of the proponents’ literature, websites etc made me settle for the former explanation.
All this could be entirely irrelevant, perhaps slightly amusing, would it not reveal a pattern which is so painfully common in alternative medicine: anyone can claim anything without fear of any type of retribution, gullible consumers are attracted through the exotic flair, VIP-promotion, long history of use etc. and follow in droves [yes, amazingly, urine therapy seems to have plenty of followers]; consequently, lives are put at risk whenever someone starts truly believing the bogus, irresponsible claims that are being made.
I do apologise for the rudeness of my words but I really do think THEY ARE TAKING THE PISS!
In my last post, we discussed the “A+B versus B” trial design as a tool to produce false positive results. This method is currently very popular in alternative medicine, yet it is by no means the only approach that can mislead us. Today, let’s look at other popular options with a view of protecting us against trialists who naively or willfully might fool us.
The crucial flaw of the “A+B versus B” design is that it fails to account for non-specific effects. If the patients in the experimental group experience better outcomes than the control group, this difference could well be due to effects that are unrelated to the experimental treatment. There are, of course, several further ways to ignore non-specific effects in clinical research. The simplest option is to include no control group at all. Homeopaths, for instance, are very proud of studies which show that ~70% of their patients experience benefit after taking their remedies. This type of result tends to impress journalists, politicians and other people who fail to realise that such a result might be due to a host of factors, e.g. the placebo-effect, the natural history of the disease, regression towards the mean or treatments which patients self-administered while taking the homeopathic remedies. It is therefore misleading to make causal inferences from such data.
Another easy method to generate false positive results is to omit blinding. The purpose of blinding the patient, the therapist and the evaluator of the outcomes in clinical trials is to make sure that expectation is not the cause of or contributor to the outcome. They say that expectation can move mountains; this might be an exaggeration, but it can certainly influence the result of a clinical trial. Patients who hope for a cure regularly do get better even if the therapy they receive is useless, and therapists as well as evaluators of the outcomes tend to view the results through rose-tinted spectacles, if they have preconceived ideas about the experimental treatment. Similarly, the parents of a child or the owners of an animal can transfer their expectations, and this is one of several reasons why it is incorrect to claim that children and animals are immune to placebo-effects.
Failure to randomise is another source of bias which can make an ineffective therapy look like an effective one when tested in a clinical trial. If we allow patients or trialists to select or choose which patients receive the experimental and which get the control-treatment, it is likely that the two groups differ in a number of variables. Some of these variables might, in turn, impact on the outcome. If, for instance, doctors allocate their patients to the experimental and control groups, they might select those who will respond to the former and those who don’t to the latter. This may not happen with malicious intent but through intuition or instinct: responsible health care professionals want those patients who, in their experience, have the best chances to benefit from a given treatment to receive that treatment. Only randomisation can, when done properly, make sure we are comparing comparable groups of patients, and non-randomisation is likely to produce misleading findings.
While these options for producing false positives are all too obvious, the next possibility is slightly more intriguing. It refers to studies which do not test whether an experimental treatment is superior to another one (often called superiority trials), but to investigations attempting to assess whether it is equivalent to a therapy that is generally accepted to be effective. The idea is that, if both treatments produce the same or similarly positive results, both must be effective. For instance, such a study might compare the effects of acupuncture to a common pain-killer. Such trials are aptly called non-superiority or equivalence trials, and they offer a wide range of possibilities for misleading us. If, for example, such a trial has not enough patients, it might show no difference where, in fact, there is one. Let’s consider a deliberately silly example: someone comes up with the idea to compare antibiotics to acupuncture as treatments of bacterial pneumonia in elderly patients. The researchers recruit 10 patients for each group, and the results reveal that, in one group, 2 patients died, while, in the other, the number was 3. The statistical tests show that the difference of just one patient is not statistically significant, and the authors therefore conclude that acupuncture is just as good for bacterial infections as antibiotics.
Even trickier is the option to under-dose the treatment given to the control group in an equivalence trial. In our hypothetical example, the investigators might subsequently recruit hundreds of patients in an attempt to overcome the criticism of their first study; they then decide to administer a sub-therapeutic dose of the antibiotic in the control group. The results would then apparently confirm the researchers’ initial finding, namely that acupuncture is as good as the antibiotic for pneumonia. Acupuncturists might then claim that their treatment has been proven in a very large randomised clinical trial to be effective for treating this condition, and people who do not happen to know the correct dose of the antibiotic could easily be fooled into believing them.
Obviously, the results would be more impressive, if the control group in an equivalence trial received a therapy which is not just ineffective but actually harmful. In such a scenario, the most useless or even slightly detrimental treatment would appear to be effective simply because it is equivalent to or less harmful than the comparator.
A variation of this theme is the plethora of controlled clinical trials which compare one unproven therapy to another unproven treatment. Perdicatbly, the results indicate that there is no difference in the clinical outcome experienced by the patients in the two groups. Enthusiastic researchers then tend to conclude that this proves both treatments to be equally effective.
Another option for creating misleadingly positive findings is to cherry-pick the results. Most trails have many outcome measures; for instance, a study of acupuncture for pain-control might quantify pain in half a dozen different ways, it might also measure the length of the treatment until pain has subsided, the amount of medication the patients took in addition to receiving acupuncture, the days off work because of pain, the partner’s impression of the patient’s health status, the quality of life of the patient, the frequency of sleep being disrupted by pain etc. If the researchers then evaluate all the results, they are likely to find that one or two of them have changed in the direction they wanted. This can well be a chance finding: with the typical statistical tests, one in 20 outcome measures would produce a significant result purely by chance. In order to mislead us, the researchers only need to “forget” about all the negative results and focus their publication on the ones which by chance have come out as they had hoped.
One fail-proof method for misleading the public is to draw conclusions which are not supported by the data. Imagine you have generated squarely negative data with a trial of homeopathy. As an enthusiast of homeopathy, you are far from happy with your own findings; in addition you might have a sponsor who puts pressure on you. What can you do? The solution is simple: you only need to highlight at least one positive message in the published article. In the case of homeopathy, you could, for instance, make a major issue about the fact that the treatment was remarkably safe and cheap: not a single patient died, most were very pleased with the treatment which was not even very expensive.
And finally, there is always the possibility of overt cheating. Researchers are only human and are thus not immune to temptation. They may have conflicts of interest or may know that positive results are much easier to publish than negative ones. Certainly they want to publish their work – “publish or perish”! So, faced with disappointing results of a study, they might decide to prettify them or even invent new ones which are more pleasing to them, their peers, or their sponsors.
Am I claiming that this sort of thing only happens in alternative medicine? No! Obviously, the way to minimise the risk of such misconduct is to train researchers properly and make sure they are able to think critically. Am I suggesting that investigators of alternative medicine are often not well-trained and almost always uncritical? Yes.