Medical Quackery
Medical Quackery
December, 2003
This article was inspired by a discussion on the "Healthfraud" Discussion List.
Sometimes reality is frustrating! And, for me, this is one of those times. I'd love to live in a perfect world. (On the other hand, it might be rather boring!) A world where basic principles and rules applied without exception. A world where scientific investigation would be able to concentrate on unraveling the mysteries of the universe. A world where scientific investigation would be able to progress steadily, unhindered by lack of funds, investigator bias, human error, deception, etc.
I sense a bit of tension in the debate regarding proposals to engage in scientific research of Complementary and Alternative Medicine (CAM). In fact, it may even sound like an oxymoron to put "scientific" and "alternative medicine" in the same sentence! As a health care consumer advocate (CA) and a science-based skeptic, I'm caught in a dilemma over this matter. I experience cognitive dissonance when contemplating the thought of using "reason" to explain "humbug"! Water and oil just don't mix.
I could easily solve the conflict by using my common sense: It is a waste of time, so don't do it! But that would violate my understanding of the first and most important duty of a consumer advocate: (a) to protect the public, not just (b) preserve my own scientific ideals.
Let's take a look at what a skeptic and a CA have in common. While not all skeptics are CAs, many, if not most, CAs are skeptics. For many different reasons they have an extra dimension to their skepticism and have become consumer advocates.
Being a skeptic and a CA implies the use of critical thinking and logical skills in a search for the truth. One way this is done is by pitting conflicting ideas against each other and deciding which side presents the best objective evidence for its case. They understand the value of Karl Popper's "Falsification" principle. Therefore, the scientific method of investigation is usually the preferred modus operandi.
Consumer advocacy implies an involvement with, and a debt to, the public. They need our help and protection, whether they realize it or not. Thus a CA has an obligation to the public that a skeptic does not have, since skepticism can be focused on many different areas other than the health care arena, and doesn't necessarily involve any obligation to anyone or anything, other than to search for the truth.
A CA firmly believes in several legitimate values and ideals. It is here that unpleasant reality can force him to make a choice between them. He may feel that he is being forced to compromise his ideals.
As a skeptic, he tries to (a) respect scientific accuracy. As a CA, he tries to (b) provide accurate information to the public, and (c) actively try to stop quackery through the creation and enforcement of relevant laws and regulations.
A consumer advocate's duties are two-fold: he has a double-edged sword in one hand and a shield in the other:
The sword is pointed at the claimant with two messages: "Prove your claim (scientifically), or feel my sword (criticism, exposure and possible litigation)."
The shield is made available to the object of the claim with the offer: "Here is accurate information to help you make an intelligent decision, based on hearing both sides of the story. If you need help, I will try to defend you."
The Burden Of Proof . . .
One of the first principles in scientific and legal matters is that "the burden of proof is on the claimant." But are there situations where it is justifiable, and actually necessary, to temporarily ignore this principle? I believe so.
Even though "the burden of proof is on the claimant", it is often not the claimant that will benefit from proving or disproving the claim. In the case of many CAM claims, the claimant is often a true believer who will just ignore the data anyway. So the question of who has "the burden of proof" (and thus, who should do the research) is irrelevant, from a consumer advocacy standpoint. (1, 16)
No, the ones that stand to benefit from attempts to prove or disprove such claims are the ones at whom the claim is directed, in other words, the "objects" of the claim - the potential users and/or victims. They may not yet be believers and should be given a chance to make intelligent and well-informed decisions. What they then do is their own responsibility.
CAM should, and in many cases can, be studied. The questions "Why?" and "By whom?" are relevant here. (2)
The advantages of doing better quality research are at least two-fold: (3)
If a claim is difficult to investigate, then it may be an exercise in futility to begin to try and do so. Wildly implausible claims that have no relation to the available body of knowledge are normally difficult or impossible to investigate, and there is no justification for using scientist's time and taxpayer's money in attempts to do so. If the claimant wants to prove such wild claims, let him do it himself. The following oft heard adages, apply doubly in these cases: "Extraordinary claims demand extraordinary evidence"; "The burden of proof is on the claimant"; "Put up or shut up!" (5)
A fool can ask a thousand questions that the wisest man can never answer in all eternity. Scientists must be careful not to play the fool's game of seeking for answers to impossible questions. They have more important uses for their time. (6)
When it becomes evident that the possibility of finding objective proof is made impossible because the modality requires evidence that lies in unmeasurable and untestable metaphysical realms, it is time for the scientists to give way to theologians and philosophers. (6)
The First Amendment
Such methodologies are not in the scientific arena, but come under the umbrella of the Constitutional separation between church and state, as stated in the First Amendment. The government should not be in the business of promoting religious doctrine in any form whatsoever.
The First Amendment forbids any government or state agency from supporting any such practice by law or economic help. The government has no right or duty to make the same type of regulations for CAM as for EBM, nor does it have any right or duty to subsidize the exercise of private beliefs with non-believing taxpayer's money. The Constitution forbids this.
Likewise it cannot interfere with the exercise of such practices, unless they are otherwise illegal and/or dangerous, especially if they involve non-consenting parties, such as children, the mentally disabled or animals. (6)
Such methodologies must declare themselves to be religious philosophies and not scientifically proven remedies, if they expect to receive constitutional protection. They are for believers, and it should be clear to all that this is the case. Nonetheless, Constitutional protection does not exempt them from criticism. (6)
Truth in advertising demands this, for example: Subluxation-based chiropractors should be required to advertise their services as an exercise of the beliefs of a member of The First Church of the Holy Subluxation". (6)
The principle: "The burden of proof is on the claimant", does not forbid curious scientists from seeking explanations for puzzling, possibly paradoxical, observations and anecdotes. The greatest value possessed by anecdotes, is that impressive anecdotes can spur to further research. Anecdotes can be considered neutral, and therefore worthy of being examined by anyone.
Evidence
There are several types of evidence that it is desirable to obtain before a therapy is advocated:
Whether to do the research or not depends on several variables, each demanding different priorities: number of anecdotes, apparent degree of success, patient safety and protection, protection of the public from misinformation, cost-benefit ratio, etc. (6, 7)
Objective Standards
Before research can begin, certain mutually agreed upon objective standards should be established such as : end states (desired effects), stopping rules, confidence limits, blinding, randomization and falsifiability. If at all possible, there should be made a written agreement with the proponent of the methodology to be researched, to the effect that the results of the research will be accepted as binding. A refusal by the claimant to make such an agreement can in certain situations be interpreted as evidence of a lack of good will, as well as a lack of responsibility and accountability. (8)
It is not possible to establish such conditions in all situations. Metaphysical and religious claims fall into this category and should not be the subject of scientific investigation, but the subject of theological discussions. But when claims are made regarding testable physical and biological facts, then science comes into the picture and can be used to test the claims.
So far, the scientific/medical community, and the alternative medicine community, cannot communicate effectively because they lack a bridge between them. This communication cannot happen until they can agree on an acceptance of the rules of logic and objective standards of proof as the bridge. The scientific community already uses these tools, while the alternative medicine community considers these tools as unnecessary, since they consider subjective anecdotes as the only proof they need.
The reason that scientists need to research CAM is that CAM practitioners usually don't understand or respect three vital things: (a) that the scientific method is the only way to find out the truth; (b) that scientific results can be checked and falsified; and (c) that the burden of proof is on the claimant. Therefore they will usually not do the research themselves. Another factor is that they are usually untrained in research methods. (9, 10)
CAM practitioners are usually uninterested in being proven wrong. (Quite natural for all people!) But they have discovered "the truth", and are therefore not interested in hearing criticism. The concept of falsifiablity is nonsense to them. While they evade and criticize any objective set of standards that can be used to measure the accuracy of their claims, they willingly exploit and use the same standards, if there is the slightest tendency it vindicates their claims, no matter how weak and unreliable the evidence. This is then used to confuse and mislead the non-scientific public. (11)
CAM practitioners often exploit the very mention of their name or modality in the media, research or regulations, even if the mention is in a negative context. If a research project has even just begun, they shout from the housetops that their modality has been scientifically proven to be efficacious. And when the completed research overwhelmingly disproves their modality, they ignore or criticize the research and continue to practice their quackery. If you loan them your shirt, they'll take your coat as well. (12, 13, 14)
As chiropractors have demonstrated, regulation gives even wider scope for abuse. They do not ask if they may expand their scope of practice, they just do it, irrespective that it encroaches on other profession's scope of practice. (12)
The very existence of government-funded research of CAM modalities is used by their proponents to legitimize their methods. The question of final results and proof does not concern them. They will often hypocritically use any excuse to make it appear that their method is legitimate, accepted, and confirmed by science, even though they use any available excuse to denigrate scientific endeavors at the same time. (12, 13, 14)
The poor ethics revealed by a lack of willingness to be held accountable for misleading statements and the poor, and sometimes dangerous, results of therapy, is reason enough to justify making an exception to the principle of "The burden of proof is on the claimant." The concern for protection of the public is a higher concern than a firm stance on this point. Therefore the research should be done, in spite of the fact that such research will be used as propaganda, regardless of the outcome.
Making an exception for this reason does not negate the validity of the principle. But dishonesty and/or lack of integrity demand that the rules of the game be changed. Since many CAM practitioners refuse to respect the rules of the game, we must counteract their negative influence by playing differently than we usually would. Otherwise they will run circles around us, treat us as naive, and continue to deceive the public.
Some unproven therapies may actually be useful, but lack proof of efficacy, simply because the research hasn't been done yet. As long as this is the case, CAM practitioners will be able to use this excuse to try and justify their use of worthless and even dangerous methods. Therefore the research needs to be done. They should have this last excuse removed from them. They can then no longer claim ignorance as an excuse.
Summary
While it is not possible to prove that an unworkable modality works, it may at times be possible to it prove that it doesn't work. Emily Rosa showed that it doesn't always have to be expensive, time consuming or done by trained scientists. But, unfortunately, it is not always that simple. (15)
Proving the efficacy of a modality is the responsibility of the claimant. Experience has shown that the exponents of many CAM modalities are not interested in attempts to disprove their pet methodology. Even though disproving it is not the responsibility of skeptics, if it can be done relatively easily, it would be in the best interests of the public that it be done. It is, after all, skeptics that are interested in debunking false and/or unproven claims.
But, it is questioned, why do it, since the true believers just "ignore the data anyway?" Casting pearls before swine has always been an exercise in futility. The thing we need to be aware of is that it is not for their sake it needs to be done. No, among the general public there are a lot of sensible, but scientifically ignorant people. It is for their sake the research needs to be done. Many of them are in a vulnerable situation. What they end up believing is dependent on who gets to them first: the quacks with their emotionally very appealing anecdotes, or the skeptics with their solid, logical facts, which effectively inoculate the potential victims from being infected with nonsense.
Time passes while we refuse to do the research. Meanwhile the quacks are getting their message out to the public. Once infected with alt med nonsense, some of them are lost for a few years, others forever, and still others more permanently: They die as a result of our hesitation.
It may be that history will show that we were correct in stating that we were not obligated to do the research, since the burden of proof was on the claimant. But we lost the battlefield to the quacks, simply because we didn't show up. We spoke to the quacks (who would not listen). and neglected to protect the public (who needed our help). The quacks won and the public lost.
Woofie sums it up quite well
""I agree with Monica here. If we leave it up to the alt.medders to prove, things will never get proven one way or another and many ordinary folks are going to get sucked in by dubious claims. "I know that it costs money and resources to test many of the alt claims, but there are ones which could be tested simply without much financial outlay. "Say we test the liver cleanse, below, for example, and on testing, it is found that the gall stones that are passed out are not gallstones but merely the result of chemical reactions between the cleanse ingredients and the digestive juices. OK, even if it is thoroughly proven, the true believers will not believe the results. We know that. However, we have a chance of changing the minds of other folks who come looking for a miraculous cure for what ails them. "We might even save a few lives by diverting folks from worthless miracle cancer cures. W:) -- Best regards, Woofie < woofie@woofess.com > < http://www.woofess.com > Dec. 12, 2000 ***********************"
References
From a discussion on the "Healthfraud" Discussion List) (*)
1
Monica Pignotti wrote:
> In response to Stan and Patrick, I think that CAM should and
> in many cases, can be studied. If the studies being done are
> of poor quality, that is easily remedied by criticising the
> methodology, as has been done with the prayer studies, and
> designing better ones....
To what end? Believers just ignore the data anyway.
When dealing with finite resources, it seems to me
that continuously "testing" bogus and unlikely claims
is just a waste of time and money. The burden of proof
is on the claimant.
David Ramey, DVM
< ponydoc@pacbell.net >
< http://www.seanet.com/~vettf >
Dec. 5, 2000
2
In response to Stan and Patrick, I think that CAM should
and in many cases, can be studied. If the studies being
done are of poor quality, that is easily remedied by
criticising the methodology, as has been done with the
prayer studies, and designing better ones.
Monica Pignotti
< pignotti@worldnet.att.net >
Dec. 5, 2000
3
Paul Knipschild: "So the idea arose at that time in the
early '90s, that the better you do the study, the worse
the result will be for the treatment, which is not only
specific I would say for acupuncture, but for alternative
medicine in general, I would say that. And the same goes
to a certain degree also for regular medicine."
Paul Knipschild: "And actually it turned out that most,
I would say almost every one of those newer studies,
was negative for homeopathy."
Link 
end quote
Peter Moran, MD
< pjmoran@gil.com.au >
Dec. 5, 2000
4
It is true, that some of CAM, like TT, is very
general and more difficult to pin down (other than
the Rosa test Patrick mentioned) in terms of claims
because they don't make specific claims, but there
are other forms of CAM, such as Hulda Clark's method
that are very specific and could easily be tested.
For example, her "liver cleanse" has a very specific
recipe and she claims that people produce "gall stones"
after drinking it although others have suggested that
the "stones" are really just the contents of the drink.
The recipe for this can even be obtained on the web
and the claim that it eliminates gall stones is very
specific. See: http://www.drclark.net/info/info.htm
Monica Pignotti
< pignotti@worldnet.att.net >
Dec. 5, 2000
5
Claims have to be evaluated in face of a body of
knowledge - those claims that are so extraordinary
as to overturn previous knowledge need to have
extraordinary evidence to support them. Given
what we know, chasing down wildly implausible
claims is almost certain to be futile.
David Ramey, DVM
< ponydoc@pacbell.net >
< http://www.seanet.com/~vettf >
Dec. 5, 2000
6
In reply to M. Pignotti, the approach you suggest
presents two problems: 1. Where does it stop? Proving
that most of this stuff does not work would require
millions if not billions of research dollars. Would
you like to be a cancer victim who died because
research funds were diverted from the valid scientific
study of your illness in order to prove that copper
bracelets do not work for arthritis or that TT is
baloney? Research funds are limited while the
imagination of CAM proponents is not. 2. I do not
believe that the CAM folks respond all that well
to scientific proof. I believe CAM is closer to a
religion than a science. The best cure for this is early
education. There may be some few forms of CAM that
are valid. Usually if the benefit is there the truth
will out. I have a modest proposal to Hulda Clark:
Prove your claims and publish your results!
Frank Stagg, MD
Dec. 5, 2000
7
If such treatments have a lot of clinical anecdotes
of successes and have promising pilot data, they are
worthy of being tested further and should be, since
science starts with first-hand observations.
Monica Pignotti
< pignotti@worldnet.att.net >
Dec. 5, 2000
8
About the only area of alt med that would stand up to
being researched is the use of dietary supplements of
various kinds. End states (desired effects) can be
specified, statisticians can specify stopping rules for
data collection and confidence limits and so on, and
blinding and randomisation are possible. Beyond that
area, I honestly can't think where any real scientific
researcher would start.
Patrick Bramwell-Wesley, PhD
< pbramwell@home.com >
Dec. 4, 2000
9
I think that the scientific method, properly and
appropriate applied, is really the only way to find
out the truth.
Monica Pignotti
< pignotti@worldnet.att.net >
Dec. 11, 2000 (DrClark list)
10
Science and research do, at least, have objective
standards and if a study has poor methodology and flaws,
these can be pointed out.
Monica Pignotti
< pignotti@worldnet.att.net >
Dec. 11, 2000 (DrClark list)
11
The whole "need more research" mantra allows the
quacks to (a) appear to be willing to submit to
the disinterested test of science; (b) buy time,
because a priori their particular form of lunacy
is actually non-testable but they can keep promising
vindication some time in the future; (c) claim
any apparently positive "test as a great triumph
and victory, no matter how lousy the experimental
design etc; and (d) continue to generate a haze of
uncertainty around their nonsensical practices so
that the non-scientific examiner may be further
confused by all the post-modernist cultural-relativity
claptrap being generated around alt med.
Patrick Bramwell-Wesley, PhD
< pbramwell@home.com >
Dec. 4, 2000
12
These points apply equally well to the business of
regulation. As Chiropractors in some jurisdictions
have demonstrated, regulation gives even wider scope
for abuse ("Must be OK, it's regulated!") because the
quacks have no tradition of group action in the
interest of professional credibility, and no
understanding of ideas such as the public interest.
Only the $ matters to them (and those who say it
doesn't are either lying or are deluding themselves).
Patrick Bramwell-Wesley, PhD
< pbramwell@home.com >
Dec. 4, 2000
13
Amen!!! In my opinion, homeopathy is the most egregious
example of this. The foggy aura of legitimacy conferred
by government-funded research is the best thing they
have going for them.
Stan Polanski, P.A.
Dec. 4, 2000
14
A string of negative studies from now until doomsday
isn't going to dissuade a magical thinker from his
delusions, while the occasional positive finding that
results from chance, fraud or error, will be widely
broadcast as "proof".
Stan Polanski, P.A.
Dec. 5, 2000
15
No amount of research is going to "prove" that a
particular alt med modality works. For example:
what on earth kind of research would one design for
the energy therapies like Reiki, TT and so on? One
simple demonstration like the Rosa test shows that
there isn't anything there to research.
Patrick Bramwell-Wesley, PhD
< pbramwell@home.com >
Dec. 4, 2000
16
I think this is nicely illustrated by a story
posted to this list earlier this week, about
a death from the alleged cancer treatment hydrazine
sulfate. This compound was found to be ineffective
in several controlled trials in the 1970's. In 1994,
the Journal of Clinical Oncology published three
placebo-controlled, double-blind trials which all
showed no benefits of hydrazine sulfate. The journal
published an editorial along with these, entitled
"Three Stakes in Hydrazine Sulfate's Heart, but
Questionable Cancer Remedies, Like Vampires,
Always Rise Again."
Thomas J. Wheeler, PhD
< tjwheeler@louisville.edu >
< Link >
Dec. 7, 2000
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