How do you fancy playing a little game? Close your eyes, relax, take a minute or two and imagine the newspaper headlines which new medical discoveries might make within the next 100 years or so. I know, this is a slightly silly and far from serious game but, I promise, it’s quite good fun.
Personally, I see the following headlines emerging in front of my eyes:
VACCINATION AGAINST AIDS READY FOR ROUTINE USE
IDENTIFICATION OF THE CAUSE OF DEMENTIA LEADS TO FIRST EFFECTIVE CURE
GENE-THERAPY BEGINS TO SAVE LIVES IN EVERY DAY PRACTICE
CANCER, A NON-FATAL DISEASE
HEALTHY AGEING BECOMES REALITY
Yes, I know this is nothing but naïve conjecture mixed with wishful thinking, and there is hardly anything truly surprising in my list.
But, hold on, is it not remarkable that I visualise considerable advances in conventional healthcare but no similarly spectacular headlines relating to alternative medicine? After all, alternative medicine is my area of expertise. Why do I not see the following announcements?
YET ANOTHER HOMEOPATH WINS THE NOBEL PRIZE
CHIROPRACTIC SUBLUXATION CONFIRMED AS THE SOLE CAUSE OF MANY DISEASES
CHRONICALLY ILL PATIENTS CAN RELY ON BACH FLOWER REMEDIES
CHINESE HERBS CURE PROSTATE CANCER
ACUPUNCTURE MAKES PAIN-KILLERS OBSOLETE
ROYAL DETOX-TINCTURE PROLONGS LIFE
CRANIOSACRAL THERAPY PROVEN EFFECTIVE FOR CEREBRAL PALSY
IRIDOLOGY, A VALID DIAGNOSTIC TEST
How can I be so confident that such headlines about alternative medicine will not, one day, become reality?
Simple: because I only need to study the past and realise which breakthroughs have occurred within the previous 100 years. Mainstream scientists and doctors have discovers insulin-therapy that turned diabetes from a death sentence into a chronic disease, they have developed antibiotics which saved millions of lives, they have manufactured vaccinations for deadly infections, they have invented diagnostic techniques that made early treatment of many life-threatening conditions possible etc, etc, etc.
None of the many landmarks in the history of medicine has ever been in the realm of alternative medicine.
What about herbal medicine? Some might ask. Aspirin, vincristine, taxol and other drugs originated from the plant kingdom, and I am sure there will be similar such success-stories in the future.
But were these truly developments driven by traditional herbalists? No! They were discoveries entirely based on systematic research and rigorous science.
Progress in healthcare will not come from clinging to a dogma, nor from adhering to yesterday’s implausibilites, nor from claiming that clinical experience is more important than scientific research.
I am not saying, of course, that all of alternative medicine is useless. I am saying, however, that it is time to get realistic about what alternative treatments can do and what it cannot achieve. They will not save many lives, for instance; an alternative cure for anything is a contradiction in terms. The strength of some alternative therapies lies in palliative and supportive care and not in changing the natural history of diseases.
Yet proponents of alternative medicine tend to ignore this all too obvious fact and go way beyond the line that divides responsible from irresponsible behaviour. The result is a plethora of bogus claims – and this is clearly not right. It raises false hopes which, in a nutshell, are always unethical and often cruel.
What is and what isn’t evidence, and why is the distinction important?
In the area of alternative medicine, we tend to engage in sheer endless discussions around the subject of evidence; the relatively few comments on this new blog already confirm this impression. Many practitioners claim that their very own clinical experience is at least as important and generalizable as scientific evidence. It is therefore relevant to analyse in a little more detail some of the issues related to evidence as they apply to the efficacy of alternative therapies.
To prevent the debate from instantly deteriorating into a dispute about the value of this or that specific treatment, I will abstain from mentioning any alternative therapy by name and urge all commentators to do the same. The discussion on this post should not be about the value of homeopathy or any other alternative treatment; it is about more fundamental issues which, in my view, often get confused in the usually heated arguments for or against a specific alternative treatment.
My aim here is to outline the issues more fully than would be possible in the comments section of this blog. Readers and commentators can subsequently be referred to this post whenever appropriate. My hope is that, in this way, we might avoid repeating the same arguments ad nauseam.
Clinical experience is notoriously unreliable
Clinicians often feel quite strongly that their daily experience holds important information about the efficacy of their interventions. In this assumption, alternative practitioners are usually entirely united with healthcare professionals working in conventional medicine.
When their patients get better, they assume this to be the result of their treatment, especially if the experience is repeated over and over again. As an ex-clinician, I do sympathise with this notion which might even prevent practitioners from losing faith in their own work. But is the assumption really correct?
The short answer is NO. Two events [the treatment and the improvement] that follow each other in time are not necessarily causally related; we all know that, of course. So, we ought to consider alternative explanations for a patient’s improvement after therapy.
Even the most superficial scan of the possibilities discloses several options: the natural history of the condition, regression towards the mean, the placebo-effect, concomitant treatments, social desirability to name but a few. These and other phenomena can contribute to or determine the clinical outcome such that inefficacious treatments appear to be efficacious.
What follows is simple, undeniable and plausible for scientists, yet intensely counter-intuitive for clinicians: the prescribed treatment is only one of many influences on the clinical outcome. Thus even the most impressive clinical experience of the perceived efficacy of a treatment can be totally misleading. In fact, experience might just reflect the fact that we repeat the same mistake over and over again. Put differently, the plural of anecdote is anecdotes, not evidence!
Clinicians tend to get quite miffed when anyone tries to explain to them how multifactorial the situation really is and how little their much-treasured experience tells us about therapeutic efficacy. Here are seven of the counter-arguments I hear most frequently:
1) The improvement was so direct and prompt that it was obviously caused by my treatment [this notion is not very convincing; placebo-effects can be just as prompt and direct].
2) I have seen it so many times that it cannot be a coincidence [some clinicians are very caring, charismatic, and empathetic; they will thus regularly generate powerful placebo-responses, even when using placebos].
3) A study with several thousand patients shows that 75% of them improved with my treatment [such response rates are not uncommon, even for ineffective treatments, if patient-expectation was high].
4) Surely chronic conditions don’t suddenly get better; my treatment therefore cannot be a placebo [this is incorrect, eventually many chronic conditions improve, if only temporarily].
5) I had a patient with a serious condition, e.g. cancer, who received my treatment and was cured [if one investigates such cases, one often finds that the patient also took a conventional treatment; or, in rare instances, even cancer-patients show spontaneous remissions].
6) I have tried the treatment myself and had a positive outcome [clinicians are not immune to the multifactorial nature of the perceived clinical response].
7) Even children and animals respond very well to my treatment, surely they are not prone to placebo-effects [animals can be conditioned to respond; and then there is, of course, the natural history of the disease].
Is all this to say that clinical experience is useless? Clearly not! I am merely pointing out that, when it comes to therapeutic efficacy, clinical experience is no replacement for evidence. It is invaluable for a lot of other things, but it can at best provide a hint and never a proof of efficacy.
What then is reliable evidence?
As the clinical outcomes after treatments always have many determinants, we need a different approach for verifying therapeutic efficacy. Essentially, we need to know what would have happened, if our patients had not received the treatment in question.
The multifactorial nature of any clinical response requires controlling for all the factors that might determine the outcome other than the treatment per se. Ideally, we would need to create a situation or an experiment where two groups of patients are exposed to the full range of factors, and the only difference is that one group does receive the treatment, while the other one does not. And this is precisely the model of a controlled clinical trial.
Such studies are designed to minimise all possible sources of bias and confounding. By definition, they have a control group which means that we can, at the end of the treatment period, compare the effects of the treatment in question with those of another intervention, a placebo or no treatment at all.
Many different variations of the controlled trial exist so that the exact design can be adapted to the requirements of the particular treatment and the specific research question at hand. The over-riding principle is, however, always the same: we want to make sure that we can reliably determine whether or not the treatment was the cause of the clinical outcome.
Causality is the key in all of this; and here lies the crucial difference between clinical experience and scientific evidence. What clinician witness in their routine practice can have a myriad of causes; what scientists observe in a well-designed efficacy trial is, in all likelihood, caused by the treatment. The latter is evidence, while the former is not.
Don’t get me wrong; clinical trials are not perfect. They can have many flaws and have rightly been criticised for a myriad of inherent limitations. But it is important to realise that, despite all their short-commings, they are far superior than any other method for determining the efficacy of medical interventions.
There are lots of reasons why a trial can generate an incorrect, i.e. a false positive or a false negative result. We therefore should avoid relying on the findings of a single study. Independent replications are usually required before we can be reasonably sure.
Unfortunately, the findings of these replications do not always confirm the results of the previous study. Whenever we are faced with conflicting results, it is tempting to cherry-pick those studies which seem to confirm our prior belief – tempting but very wrong. In order to arrive at the most reliable conclusion about the efficacy of any treatment, we need to consider the totality of the reliable evidence. This goal is best achieved by conducting a systematic review.
In a systematic review, we assess the quality and quantity of the available evidence, try to synthesise the findings and arrive at an overall verdict about the efficacy of the treatment in question. Technically speaking, this process minimises selection and random biases. Systematic reviews and meta-analyses [these are systematic reviews that pool the data of individual studies] therefore constitute, according to a consensus of most experts, the best available evidence for or against the efficacy of any treatment.
Why is evidence important?
In a way, this question has already been answered: only with reliable evidence can we tell with any degree of certainty that it was the treatment per se – and not any of the other factors mentioned above – that caused the clinical outcome we observe in routine practice. Only if we have such evidence can we be sure about cause and effect. And only then can we make sure that patients receive the best possible treatments currently available.
There are, of course, those who say that causality does not matter all that much. What is important, they claim, is to help the patient, and if it was a placebo-effect that did the trick, who cares? However, I know of many reasons why this attitude is deeply misguided. To mention just one: we probably all might agree that the placebo-effect can benefit many patients, yet it would be a fallacy to assume that we need a placebo treatment to generate a placebo-response.
If a clinician administers an efficacious therapy [one that generates benefit beyond placebo] with compassion, time, empathy and understanding, she will generate a placebo-response PLUS a response to the therapy administered. In this case, the patient benefits twice. It follows that, merely administering a placebo is less than optimal; in fact it usually means cheating the patient of the effect of an efficacious therapy.
The frequently voiced counter-argument is that there are many patients who are ill without an exact diagnosis and who therefore cannot receive a specific treatment. This may be true, but even those patients’ symptoms can usually be alleviated with efficacious symptomatic therapy, and I fail to see how the administration of an ineffective treatment might be preferable to using an effective symptomatic therapy.
We all agree that helping the patient is the most important task of a clinician. This task is best achieved by maximising the non-specific effects [e.g. placebo], while also making sure that the patient benefits from the specific effects of what medicine has to offer. If that is our goal in clinical practice, we need reliable evidence and experience. Therefore one cannot be a substitute for the other, and scientific evidence is an essential precondition for good medicine.
Guest Post by Louise Lubetkin
A study published last week in the New England Journal of Medicine (NEJM) has brought to light some stark differences in the way that physicians and their patients see the role of chemotherapy in the management of advanced (i.e., metastatic) cancer.
Physicians who treat patients with advanced cancer know only too well that while chemotherapy can sometimes be helpful in easing symptoms, and may temporarily slow tumor growth, it cannot reverse or permanently cure the disease. In other words, when chemotherapy is given to patients with advanced cancer it is always given with palliative rather than curative intent. However, this is a distinction that a sizeable majority of cancer patients apparently do not fully understand.
In the NEJM-study, which involved 1193 patients with advanced lung or colorectal cancer, only 20-30 percent of patients reported understanding that chemotherapy was not at all likely to cure their cancer. The remainder, a full 81 percent of patients with colorectal cancer and 69 percent of patients with lung cancer, continued to believe, even when told otherwise, that chemotherapy did indeed offer them a significant chance of cure.
The study raises important questions concerning possible lack of informed consent: would patients still accept chemotherapy if they knew that it stood no chance of curing them? The authors cite a study which revealed that patients – especially younger patients – would opt for chemotherapy if it offered even a 1 percent chance of cure, but would be considerably less willing to accept the same treatment if it offered only a significant increase in life expectancy. In the light of this, the authors write, “…an argument can be made that patients without a sustained understanding that chemotherapy cannot cure their cancer have not met the standard for true ongoing informed consent to their treatment.”
Because of the searching nature of the questions raised by the NEJM-study, and its potential ethical ramifications, it seems destined to be picked up by advocates of alternative medicine and used as a cudgel against standard medicine. To promoters of alt med, oncology represents a cynical institutionalized conspiracy to obstruct the use of purported “natural” cures, and chemotherapy is simply a license to poison patients in pursuit of profit. Take, for example this fevered headline and article from the Natural News website : “Chemo ‘benefits’ wildly over-hyped by oncologists; cancer patients actually believe they will be ‘cured’ by poison.”
“…chemotherapy is nothing but a sham “treatment” that puts cancer patients through needless pain and suffering while making the cancer industry rich,” continues the Natural News article.
“And perhaps the most disturbing part about this now-normalized form of medical quackery is that oncologists typically fail to disclose to their patients the fact that chemotherapy does not even cure cancer, which gives them false hope.”
(Which incidentally is pretty rich, coming from a website which carries, on the same page as this article, an ad which reads “How to CURE almost any cancer at home for $5.15 a day.”)
In fact, as more than one study has previously demonstrated, the majority of oncologists do indeed try their best to convey the incurable nature of metastatic cancer, and do mention the limited aims of chemotherapy in this setting. However, patients themselves are not always psychologically receptive, and are not always immediately able to confront the bleak truth. Neither, understandably, are physicians always eager to dwell on the negative aspects of the situation during “bad news” consultations. While two thirds of doctors tell patients at their initial visit that they have an incurable disease, only about a third explicitly state the prognosis. And even when prognosis is explained, more than one third of patients simply refuse to believe that treatment is unable to cure them (see Smith TJ, Dow LA, Virago EA, et al., here).
Moreover, patients’ initial reaction to the news that their cancer has recurred, or has metastasized, is typically “What can be done?” rather than “When will I die?” Similarly, physicians – who, contrary to the calumnies of alt med conspiracy-mongers, are just as human as the rest of us, and just as averse to being the bearer of awful news – are apt quickly to follow their patients’ lead away from the hopelessness and finality of the situation and towards a practical discussion of treatment options, a realm in which they feel far more at home.
Significantly, the NEJM-study found that the very physicians who most explicitly drummed home the message that chemotherapy would not cure advanced cancer were consistently given the lowest marks for empathy and communication skills by their patients. Conversely, those physicians who projected a more optimistic view of chemotherapy were perceived as better communicators.
“In an era of greater measurement and accountability in health care,” the study concludes, “we need to recognize that oncologists who communicate honestly with their patients, a marker of high quality of care, may be at risk for lower patient ratings.”
In an accompanying NEJM editorial titled “Talking with Patients about Dying” (unfortunately it’s behind a paywall but you can read a summary here), Thomas J. Smith, MD, and Dan L. Longo, MD, provide a trenchant commentary on this important subject.
“Chemotherapy near the end of life is still common, does not improve survival, and is one preventable reason why 25 percent of all Medicare funds are spent in the last year of life. Patients need truthful information in order to make good choices. If patients are offered truthful information – repeatedly – on what is going to happen to them, they can choose wisely. Most people want to live as long as they can, with a good quality of life, and then transition to a peaceful death outside the hospital. We have the tools to help patients make these difficult decisions. We just need the gumption and incentives to use them.”
As these uncompromisingly candid editorialists point out, chemotherapy is a crude and ineffective treatment for advanced cancer. But to claim, as do many proponents of alternative approaches to cancer, that palliative chemotherapy represents a highly lucrative business built on the deliberate deception of dying patients, is a clear-cut case of the pot calling the kettle black.
When advocates of alternative cancer therapies have subjected their own highly profitable nostrums to the same kind of scientific scrutiny and honest, unsparing self-criticism as the NEJM researchers and editorialists, and when they produce evidence that their remedies and regimens, their coffee enemas and latter-day reincarnations of laetrile offer greater efficacy, whether palliative or curative, than chemotherapy, then, and only then, will they will have earned the right to criticize rational medicine for its shortcomings.
Guest post by Louise Lubetkin
A few months ago The Economist ran one of its Where Do You Stand? polls asking readers whether alternative medicine should be taught in medical schools:
In Britain and Australia, horrified scientists are fighting hard against the teaching of alternative therapies in publicly funded universities and against their provision in mainstream medical care. They have had most success in Britain. Some universities have been shamed into ending alternative courses. The number of homeopathic hospitals in Britain is dwindling. In 2005 the Lancet, a leading medical journal, declared “the end of homeopathy”. In 2010 a parliamentary science committee advised that “the government should not endorse the use of placebo treatments including homeopathy.” So, should alternative medicine be treated on a par with the traditional sort and taught in medical schools?
It may surprise you to discover that more than two thirds of the almost 43,000 respondents were of the opinion that yes, it should.
Given that the use of alternative therapies is now so widespread, a plausible case can be made for giving medical students a comprehensive overview of the field as part of their training. But that’s not at all what the poll asked. Here again is how it was worded:
So, should alternative medicine be treated on a par with the traditional sort and taught in medical schools? (emphasis added)
That such a hefty majority of those who responded – and Economist readers are generally affluent and well-educated – came out firmly in favour not just of the teaching of alternative medicine but explicitly of parity between it and standard medicine, is both a reflection of the seemingly unstoppable popularity of alternative medicine and also, in a wider sense, of just how respectable it has become to be indifferent to, or even overtly hostile towards science.
It is ironic that since its very first issue in 1843 The Economist has proudly displayed on its contents page a mission statement declaring that the magazine is engaged in “a severe contest between intelligence, which presses forward, and an unworthy, timid ignorance obstructing our progress.”
It would seem that a significant sample of its poll-answering readership has a somewhat distorted vision of the struggle between intelligence and ignorance. In this postmodern worldview truth is relative: science is simply one version of reality; anti-science is another – and the two carry equal weight.
The very term “alternative medicine” – I use that expression with the greatest reluctance – is itself an outgrowth of this phenomenon, implying as it does that there are two valid, indeed interchangeable, choices in the sphere of medicine, a mainstream version and a parallel and equally effective alternative approach. That the term “alternative medicine” has now so seamlessly entered our language is a measure of how pervasive this form of relativism has become.
In fact, alternative medicine and mainstream medicine are absolutely not equivalent, nor are they by any means interchangeable, and to speak about them the way one might when debating whether to take the bus or the subway to work – both will get you there reliably – constitutes an assault on truth.
How did alternative medicine, so very little of which has ever been conclusively shown to be of even marginal benefit, achieve this astounding degree of acceptance?
Certainly the pervasive and deeply unhealthy influence of the pharmaceutical industry over the practice of medicine has done much to erode public confidence in the integrity of the medical profession. Alternative medicine has nimbly stepped into the breach, successfully casting itself as an Everyman’s egalitarian version of medicine with a gentle-sounding therapeutic philosophy based not on pharmaceuticals with their inevitable side effects, but on helping the body to heal itself with the assistance of “natural” and freely available remedies.
This image of alternative medicine as a humble David bravely facing down the medico-pharmaceutical establishment’s bullying Goliath does not, however, stand up well to scrutiny. Alternative medicine is without question a hugely lucrative enterprise. Moreover, unlike the pharmaceutical industry or mainstream medicine, it is almost entirely unregulated.
According to the US National Institutes of Health, in 2007 Americans spent almost $40 billion out of their own pockets (i.e., not reimbursed by health insurance) on alternative medicine, almost $12 billion of which was spent on an estimated 350 million visits to various practitioners (chiropractors, naturopaths, massage therapists, etc.) The remaining $28 billion was spent on non-vitamin “natural” products for self-care such as fish oils, plant extracts, glucosamine and chondroitin, etc. And that’s not all: on top of this, sales of vitamin and nutritional supplements have been estimated to constitute a further $30 billion annually.
And then, of course, there’s the awkward fact of its almost total lack of effectiveness.
Look at it this way: illness is the loneliest and most isolating of all journeys. In that bleak landscape, scientifically validated medicine is not just the best compass and the most reliable map; it’s also the truest friend any of us can have.
So, should alternative medicine be treated on a par with the traditional sort and taught in medical schools?
Not on your life.
Why another blog offering critical analyses of the weird and wonderful stuff that is going on in the world of alternative medicine? The answer is simple: compared to the plethora of uncritical misinformation on this topic, the few blogs that do try to convey more reflected, sceptical views are much needed; and the more we have of them, the better.
But my blog is not going to provide just another critique of alternative medicine; it is going to be different, I hope. The reasons for this are fairly obvious: I have researched alternative medicine for two decades. My team and I have conducted about 40 clinical trials and published more than 100 systematic reviews of alternative medicine. We were by far the most productive research unit in this area. For 14 years, we hosted an annual international conference for researchers in this field. I know many of the leading investigators personally, and I understand their way of thinking. I have rehearsed every possible argument for or against alternative medicine dozens of times.
In a nutshell, I am not someone who judges alternative medicine from the outside; I come from within the field. Arguably, I am the only researcher in this area who is willing [or capable?] to state publicly what is wrong with alternative medicine. This is perhaps one of the advantages of being retired and writing a blog in an entirely private capacity.
People who have criticised this or that alternative therapy without first-hand experience of it have always been dismissed by believers as ill-informed; the argument usually is “this guy does not know what he is talking about”. Thus criticism from the outside was hardly ever taken seriously by those who needed it most. Yet it would be difficult to dismiss my arguments on such grounds: I can demonstrate that I have first-hand experience and know what I am talking about. I am clearly not an outsider.
People who criticise alternative medicine tend to claim that all of it is unscientific rubbish which we should discard. However, I am not convinced that this opinion is correct. I aim to adhere to the principles of evidence-based medicine and know that they can be applied to alternative medicine as much as to any other area of healthcare. This means that I will not dismiss everything that comes under the umbrella of alternative medicine. Our research has shown some treatments to work for some conditions, and where this is the case, I will always say so.
What follows is, I think, quite simple: this blog will differ from other blogs on the subject. It will provide critical evaluation because, in my view (and here I will express my views, not those of my Uni or anyone else), this is what is needed. But it will not engage in wholesale alternative medicine-bashing. Most importantly, it will provide comments and perspectives that are based on many years of conducting and publishing research in this area.
Since first writing these lines, it has occurred to me that it might be nice to welcome a few guest-bloggers to express their opinions. Anyone who feels like contributing should therefore contact me, and we will see what we can work out.
Before we start discussing some of the the issues around alternative medicine, let me establish a few ground rules for the debates on this blog. I do like clearly expressed views and intend to be as outspoken as politeness allows. I hope that commentators will do the same, no matter whether they agree or disagree with me. Yet a few, simple, principles should be observed by everyone commenting on my blog.
Libellous statements are not allowed.
Comments must be on topic.
Nothing published here should be taken as medical advice.
All my statements are made in a private capacity and are comments in a legal sense.
Conflicts of interest should always be disclosed.
I will take the liberty of stopping the discussion on any particular topic, if I feel that enough has been said and things are getting boring or repetitive.