Confessions of a Quackbuster

This blog deals with healthcare consumer protection, and is therefore about quackery, healthfraud, chiropractic, and other forms of so-Called "Alternative" Medicine (sCAM).

Sunday, June 05, 2005

Effectiveness & Evidence: The Cornerstones of Modern Medicine

Effectiveness & Evidence:
The Cornerstones of Modern Medicine

I'd like to start with a source:

Clinical review
ABC of complementary medicine

What is complementary medicine?
Catherine Zollman, Andrew Vickers.
BMJ 1999;319:693-696 ( 11 September )

Under the following heading is a good chart:

"Unhelpful assumptions about complementary medicine"

One of the assumptions named is the following:

"Unproved" - There is a growing body of evidence that certain complementary therapies are effective in certain clinical conditions.


The quote above from Zollman & Vickers is problematic. If it is allowed to stand as is - unclarified, unchanged, and unchallenged - it creates a dangerous situation, with far-reaching consequences. It muddies up the very definition of what can be called "complementary" & "alternative", IOW what we refer to as so-Called "Alternative Medicine" (sCAM). It would remove the "so-called". I doubt that this is the intention of Zollman & Vickers, and it should be possible for them to openly make such a clarification in writing. I'm sure that this is an unintended situation, and that they have also learned more since writing the above, which is an excellent clinical review.

Allowing this idea to go unchallenged can aid in the official establishment of two parallel systems of healthcare, both of which can claim legitimacy *as regards scientific proof of effectiveness*. Such a situation should not be allowed. That two systems exist is a fact we can't change, but that they are fundamentally different as regards their scientific legitimacy should be emphasized. Zollman & Vickers correctly point out that many of the differences are not ironclad, and there is plenty of cross-over, which makes their other comments regarding "unhelpful assumptions" a good summary.

As good as their clinical review is, on this one point I cannot agree. This point should be changed. If a therapy is proven by convincing evidence to be effective, then it is no longer "alternative", but becomes EBM! Effectiveness and evidence are the cornerstones of modern medicine, and the most vital differences between it and other things that claim to be medicine.

What Zollman & Vickers state (are proposing?) seems to be a situation where a therapy can exist in limbo, starting with the point at which effectiveness has been proven, until it is *actually & practically* fully adopted into the practice of modern medicine because it has become evidence-based. Even after it is so accepted, the sCAM crowd, with their myriad weird, unproven, disproven, and even dangerous methods, will still be able to claim the method as part of sCAM. The allowance of their 100% unproven & disproven status to gradually be changed to a 99/1, 98/2, 97/3 ratio of unproven/proven, will be used by them to legitimize the 99% unproven and disproven portion. But that portion isn't and can never be legitimate.

But that would not actually be what is happening. Although the ratio would change, because that's how statistics and mathematics work, the sCAM system would still retain 100% of its unproven, disproven, nonsensical, and dangerous methods, and would just add the effective methods to it. So the relationship would look more like this: 100+1, 100+2, etc.

What would end up happening would be that there would eventually become one officially recognized system of healthcare, with no dividing line between what is proven and what is nonsense. It would be one long continuum, with practitioners being able to do their own thing, and it being politically incorrect to make distinctions regarding quality, effectivity, efficacy, etc. It would make no difference what quality of education one had, nor if there were a difference between truth and error, EXCEPT to the patient. Of course this is what the quacks want. Their status is more important to them than the consequences to their customers. They don't like the existence of the words "quackery", "unproven", "falsehood", and "wrong", and would like to stamp them out. They would like to deconstruct such concepts and make them politically incorrect. The statement by Zollman & Vickers paves the way for this, although I doubt that this has been their intention.

It is true that some accepted and scientifically proven methods of therapy have their origins in folk medicine and off-beat practitioners. Modern medicine is eclectic. It cares not where a therapy originates from. Effectiveness is the factor that ultimately is the requirement for acceptance. Any method that has proven that it can float, has been skimmed off the top and adopted into modern medicine. What is left in the barrel is still junk, that falsely claims to do what it can't.

What sCAM wants to do is dumb-down modern medicine. It wants to drag the whole garbage heap into the house, just because a pearl might remotely happen to be in it.

Let us remember that sCAM is still "so-called", and is not a true alternative to EBM or modern medicine. It's a mixed bag of true believers, con artists, the deceived, the ignorant, the cunning, the "arrogance of ignorance", the "little knowledge that's a dangerous thing", the half-done studies, the N=1, the myriad anecdotes, etc. Only promising methods deserve any funding, and they should not be promoted until proven. When proven, they automatically become EBM and are incorporated into modern medicine, where promotion and use is legitimate.

What Zollman & Vickers do is to correctly recognize that modern medical practice isn't exactly the same thing as EBM. What they describe is the way things are, not how they should be. And since definitions have a strong tendency to determine how reality gets formed, not just to describe it, an incorrect definition will be formative for the future of legitimate healthcare. Such a misleading definition should be changed as soon as possible. I am not content to only describe the present of healthcare, but desire to influence its future.

I contend that "proof of effectiveness" is THE dividing line between sCAM and EBM. Since EBM is the exclusive property of modern medicine, and modern medicine is continually attempting to evidence base its methods, it is also willing to abandon practices that can be conclusively proven to be without effect. This is not the case with sCAM. It has never abandoned any ineffective methods.

The dissimilarity to EBM is very striking, in that modern medicine is becoming more and more firmly rooted in fact and proof, while sCAM is moving away from it, and is retreating more and more into undefinable and untestable metaphysical realms. The separation between scientific medicine and religion must be maintained. "There is medicine and something else that is not medicine." - Edward Murray

This "proof of effectiveness" dividing line is worth defending as a shibboleth. While other points may be of interest and up for discussion as matters in a gray zone, the pronouncements made as to this dividing line determine which camp one belongs to. This point is the defining No Man's Land. There is no gray zone in this regard.

The position one takes on this matter is a decisive shibboleth. It exposes whether you understand the issues or not, and whether you are supporting or dumbing down modern medicine. It shows which direction you're going, and which side of the fence you are on, or will land on, when you fall off. Uncertainty in this matter is unsafe, both for yourself, and for others.

Definitions are not only descriptive, they are also formative. The muddied definition in the clinical review by Zollman & Vickers leads to chaos and anarchy. It needs to be officially and publicly clarified, so that what it forms will be clear, concise and effective.

October 2002



"There cannot be two kinds of medicine - conventional and alternative. There is only medicine that has been adequately tested and medicine that has not, medicine that works and medicine that may or may not work. Once a treatment has been tested rigorously, it no longer matters whether it was considered alternative at the outset. If it is found to be reasonably safe and effective, it will be accepted." - Angell M, Kassirer JP, "Alternative medicine--the risks of untested and unregulated remedies." N Engl J Med 1998;339:839.


"There is no alternative medicine. There is only scientifically proven, evidence-based medicine supported by solid data or unproven medicine, for which scientific evidence is lacking. Whether a therapeutic practice is 'Eastern' or 'Western,' is unconventional or mainstream, or involves mind-body techniques or molecular genetics is largely irrelevant except for historical purposes and cultural interest. As believers in science and evidence, we must focus on fundamental issues-namely, the patient, the target disease or condition, the proposed or practiced treatment, and the need for convincing data on safety and therapeutic efficacy." - Fontanarosa P.B., and Lundberg G.D. "Alternative medicine meets science" JAMA. 1998; 280: 1618-1619.


"The "alternative" folks have had their way with the language. Treatments are "alternative" and "complementary" and "integrative" but the fact is that they're not a legitimate alternative if they don't do anything, they're not "complementary" if they don't add to anything but expense and they don't need to be "integrated" if they're just a waste of time and money." - David Ramey, DVM


Alternative has two possible meanings. Correctly employed, it refers to methods that have equal value for a particular purpose. (An example would be two antibiotics capable of killing a particular organism.) When applied to unproven methods, however, the term can be misleading because methods that are unsafe or ineffective are not reasonable alternatives to proven treatment. To emphasize this fact, we place the word "alternative" in quotation marks throughout this book whenever it is applied to methods that are not based on established scientific knowledge.


"The word 'alternative' appears in quotation marks because the methods it characterizes are not true alternatives. A true alternative to an effective health-care method is another method that has been proven effective. The methods described herein are ineffective, unproven, or both." - Kurt Butler (1992) A Consumer's Guide to "Alternative Medicine." Buffalo: Prometheus Press.


> It is apparent to me that the simply black and white view of
> alt-med (AM)/evidence-based-med (EBM) is dysfunctional and
> often leads to quack busters and skeptics looking silly.

"Recently we on the list have begun to use the term evidence-based medicine instead of "traditional" medicine. Of course, the opposite of evidence-based medicine is not "alternative medicine," but "unproven medicine." Dr. Dean Edell was the first person I heard divide medicine in this manner: what is known to work, what is known not to work, and what is still unsatisfactorily investigated.

"Now, can you honestly say that if you were a physician, you could, in good conscience, recommend that a patient take a substance or undergo a procedure which was either known to be ineffective or the efficacy (and dangers) of which were unknown?"

Lauren Eve Pomerantz


> It has been my observation that your group's use of the word fraud
> or quackery is used altogether too quickly to condemn new and
> emerging concepts of therapy that do not conform to your
> experiences and background.

"It's the level of evidence of effectiveness, not definitions of effectiveness that is the crux. In the present climate the probabilities are very high that any "new and emerging concepts of therapy" that surface without paying heed to conventional standards of evidence will be fraud, quackery, or the outcome of delusion. The coinage of medical innovation has been debased by just too many shaky contenders, don't you think?

"I would also point out that Medicine is as tough on its own innovators as it is on those that might be regarded as outsiders. likes to point this out when it wants to portray us as closed-minded.

"This is why---

1. There have been far too many bitter experiences within mainstream Medicine of false leads, of enthusiasts reporting spectacular results that others cannot confirm. It's "a hundred times bitten, a thousand times shy", to coin an aphorism.

2. Medicine is an evolving discipline. It progresses by gradually building up knowledge. Any proven new discoveries generate a flurry of research activity elucidating mechanisms, refining and improving treatments, and following leads into spin-offs. It has to know that the initial lead is sound. Alternative medicine grossly underestimates the quality of evidence needed. It also places quite unwarranted significance on occasional positive trial results amongst a lot of negative ones, and on tricky vivo studies.

3. There is a limited amount of research funds and resources available to Medicine. Especially with so many claimants, the onus has to be upon the promoters of the novel treatment to ensure that it proves itself. If they are not prepared to do this, then it's just tough luck.

"There is also the prevalent problem that the nature of so many alternative modalities is truly incompatible with other physical, chemical and biomedical knowledge. When the only evidence put forward is clinical experiences that can be mimicked by placebos in the right environment, we can be justified in thinking such modalities are probably quackery. I am sure we overstate our case on occasions, but for the reasons given above, and in the interests of encouraging reform in, this is perhaps forgivable."

> Rather than doing an extensive and exhaustive review of the
> particular therapy it seems to be much easier to condemn it
> or at least put it into the catagory of "unproven" which when
> it comes from an organization such as the National Council
> against Health Care Fraud implies that this therapy could
> well be fraudulent but the group has just not had a chance to
> prove it. I would think that "effectiveness" must be defined
> carefully in order to use this as a "yardstick" to measure
> whether a therapy is of no value, some or mild or slight
> value, moderate, partially, sometimes of value, most or all
> of the time. Rather than using ill defined values such as
> these terms, perhaps the FDA has a measure that should be used.
> I remember Trental in their clinical trials was able to
> demonstrate a 20% increase in walking distance as compared
> to placebo and this was deemed effective apparently by the
> FDA. Yet to me, 20% is not much more than placebo so is this
> term a variable term where we change its definition whenever
> we want? I am confused about this term and would very much
> like to see what your group agrees upon for a definition of
> this term.

"I don't think a general definition is possible. With minor non-life-threatening conditions, being significantly better than placebo in three independently performed good quality double-blind placebo-controlled trials would be excellent. Placebo controlled trials can't generally be used in the treatment of cancer and many other more serious conditions, but often objective end-points like death rates and objective remission are available to allow treatments to be compared."

Peter Moran, MD


"It is problematic that while the established health care system is actively trying to weed out ineffective methods, the CAM system is searching through the garbage heap of discarded and disproven methods, in an attempt to revive and invent methods for which proof is not only lacking, but for which there is often adequate proof of lack of effect."


One thing that is very important in "marketing" ideas like this is to control the vocabulary of the debate. For example, the alternative crowd has appropriated "alternative" which makes the listener see it as a "valid" alternative. Similarly, their mantra has appropriated "safe," "natural," "gentle" and so on.

To undo this, it is necessary to change the vocabulary, often by just consistently using terms, clever phrases and other things like this that allows control over the debate.

Yesterday, I saw for the first time in a post by Eric Hoy the use of the umbrella term SCAM to describe these folks. That is beautiful. It takes their words and uses them against while at the same plants firmly in the mind of those listening to the debate that this stuff is a scam. By repeating this enough and using it often, it may be possible to strip this crowd of the advantage they now have in the debate which makes their potions and therapies seem legitimate, merely "alternatives," "complements" to real medicine.

There are other less clever ways of doing this. Instead of accepting their terminology, "alternative," it can always be referred to as "so-called" alternative, driving home the point that there is medicine and something else that is not medicine.

That little phrase "there is medicine, and there is fraud" is another way of making this point.

Cathy threw out the beautiful line "Data" is not the plural of anecdote" in a message today.

What a great answer to their assertion that there are studies supporting these SCAMs.

Edward Murray

October 2002