For the last couple of days (this is an old draft I’m just now posting so this time is wrong) I’ve been posting, or should I say embroiled, in a thread on the xkcd forums about alternative “medicine”. The thread was started by a user who is, for whatever reason, under the impression that only alterniative “medicine” can help his brother.
It starts with an email forward, which alerts us all to the “crisis in health freedom”, whatever “health freedom” might mean, which is supposedly being caused by someone called “the FDA”. This is wrong for a start; the US government’s body which regulated medicines consistently refers to itself simply as “FDA”. This is a pedantic point, but if you don’t even know the name of the body you’re protesting against, how can I expect you to understand thier policy?
So anyway, “the” FDA have this new draft guidance document. In a nutshell, it seeks to clarify what is and is not subject to FDA regulation, specifically relating to CAM, or “complimentary and alternative medicine”.
But no. According to the email forward, ‘by using the term “Medicine” rather than “Modality” for CAM practices, the FDA sets the stage so that anyone who is not a licensed physician is breaking the law by using these modalities since they are therefore “practicing medicine without a license.‒ What the hell is an “alternive modality”? Either this stuff is medicine, in which case is should be (and is — this document is a clarification of existing rules, not a change in legislation or policy) subject to the same rules and regulation as conventional medicine, or it isn’t, in which case, what the hell is it for?
“Conventional medicine” is my preferred term for the usual kind of treatments and drugs you’ll get from pharmacies and doctors. Some people favour the term “allopathic” medicine, which literally means the opposite of “homeopathic medicine” — in homeopathic ‘medicine’ you use a tiny amount (often, none) of a substance that would cause the symptoms being experiences, and in allopathic medicine you use a substance which would cause the opposite effect. I don’t like using the word “allopathic” to describe conventional medicine, though, because things like immunisations are, from a strictly etymological point of view, homeopathic. The term used in the email forward is “traditional medicine”. I think this is symptomatic of a wider problem — people, particularly in the US, are increasingly thinking of science as a tradition.
“Traditional” medicine really should be used to describe things like Chinese traditional ‘cures’ — which are really alternative “medicine”. Conventional medicine, on the other hand, is arrived at by a strict, objective scientific process (in theory; there are problems with this process’ implementation certainly, but they’re not massive problems in general, especially not when compared to the unregulated gibberish touted as medicines by these “alternative” quacks).
The email forward then goes on to explain that “THIS IS A HUGE ISSUE FOR PEOPLE WHOSE ATYPICAL BIOCHEMICAL NEEDS ARE NOT ADDRESSED OR EVEN ACKNOWLEDGED BY TRADITIONAL MEDICINE.” Now, call me a cynic if you like (I won’t mind; I am a cynic), but it seems to me that conventional medicine (whoever that is supposed to refer to — certainly there’s no central body of scientific consensus who arbitrate on these things; possibly it refers to FDA) would acknowledge anything that can be shown to exist in a clinical trial? And anything that can’t — surely doesn’t exist?
The problem, really, is that there’s a growing and alarming trend for “complimentary and alternative medicine” to be viewed as perfectly valid and effective even when it can’t be proven to work scientifically. The theory is that these things (homeopathy, acupuncture, crystal healing and what have you) are necessarily outside science, and science is the wrong tool to measure their effectiveness. This is bunk for a number of reasons, and hence needs debunking.
The first reason is that science is, as I’ve mentioned, not a tradition or a convention. It is simply any objective studies designed to test a hypothesis. Any and all hypotheses will do, as long as they make some measurable claim. A claim like “people who use this medicine will recover more than people who don’t” is clearly measureable, and yet whenever scientists try to measure it, they find the claim is false. There are two different conclusions that can be drawn from this. The people whose making a lot of money depends on people believing in these claims tend to draw the conclusion that science is therefore somehow inadequate to prove the claim. The second conclusion is that the claim is false. Occam’s Razor seems to suggest one of these options over the other. I’ll leave it as an exercise for the reader to determine which.
CAM advocates tend to argue in favour of the first on the grounds that conventional medicine is good for normal people, and CAM is good for certain people; people with “atypical biochemical needs” or people who have been failed by conventional medicine. This is really exactly the same ploy as teh anti-wifi crowd are using: trials don’t show an effect because only a tiny subset of people are affected. But this can be tested too, and routinely it isn’t. When they test for and prove this claim it will be accepted. Until then, it will be ridiculed. I do not believe that these “atypical biochemical needs” exist, except those people on the X Files born without some gland or other who have to harvest the appropriate bodyparts from other people.
To my mind, though, the far bigger problem with it is that conventional medicine is, by definition, medicine which is generally agreed by scientists and doctors to work, and alternative medicine is, again by definition, anything else. That is, anything which it is not generally agreed by suitably qualified boffins to work. As such, if you say alternative “medicines” exist somehow “outside” science and don’t need scientific proof to be sold, then anything which is not proven need not be proven, and the only things that need proof by definition already have it. Clearly that’s stupid and unworkable; pharmacology companies could sidestep FDA completely simply by saying “oh, it’s alternative”.
For their part, FDA have extremely wisely decided that the simplest and best way out of the problem is to make no legal distinction between conventional and alternative medicines. That levels the playing field and surely nobody can complain about that?
Well no, they can’t, but they do. This page allows, indeed encourages, users to send the following message to FDA (who are still gathering puclic comments on their new draft guidance document):
I assert my fundamental right to control my own health and health care. I want Complementary and Alternative Modalities (”CAM”) to be freely available and I endorse the comments of the Natural Solutions Foundation which were submitted on April 6, 2006 and which follow
There’s quite a lot of comments, so I’m going to trim them somewhat and make fun of the amusing parts, such as the name of the correspondants in question.
These comments are submitted by Major General Albert N. Stubblebine, Rima Laibow, MD and Ralph Fucetola, JD–
Hahaha. Stubblebine! I don’t even know if I believe that’s a real name. (I looked him up on Google, and apparently famous nutcase and HIV-denialist Dr Rath is angry at him for intimidating my younger brother. Bastard.)
–on behalf of Natural Solutions Foundation with regard to the Food and Drug Administration’s draft “Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration.†They are submitted with reference to the request of FDA for comments on the proposed Guidance stated at: http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-3259.htm.
The Natural Solutions Foundation is a tax exempt, recognized nongovernmental organization active in the United States and internationally, communicating Natural Solutions to the many health problems caused by government intervention, with emphasis on FDA and Codex Alimentarius over-regulation of natural foods and supplements.
Complementary and Alternative Modalities (CAM), including traditional remedies and nutrition to achieve and maintain a healthy status, are preferred by many Americans to so-called “standard†allopathic medical treatment, primarily due to the well-documented iatrogenic death and disabilities, the dangerous side effects and persistent failures of the so-called “standard†model. The Dietary Supplement and Natural Remedies market has grown to over $28 billion dollars annually as Americans consistently vote with their dollars choosing CAM products out of un-reimbursed funds.
Here, Major Stubblebine (hehe) puts the term “standard” in inverted commas, to imply that it is a sham. I did this earlier when I put the word “medicine” in inverted commas wherever it was preceded by the term “alternative”. See, I can use punctuation to make a point, too. In any case, the “persistent failures” of the “so-called standard model” (such as, presumably, the location of that damn elusive Higgs boson) are utterly irrelevant to the worth or otherwise of any alternative model. They are subject to the same rules. If standard practices can be shown not to work they are banned. This happens relatively often. Similarly, if ‘alternative’ practices can be shown to work, they are allowed, and adopted as standard.
The fact that “the Dietary Supplement and Natural Remedies market has grown to over $28 billion dollars annually as Americans consistently vote with their dollars choosing CAM products out of un-reimbursed funds” is also, you may notice, part of my argument for the guidance document: these companies are (according to FDA’s definitions in the link above), commiting “health fraud” if their remedies don’t work, to the tune of $28 billion a year. That’s surely worse than commiting health fraud for less money?
The Foundation urges the FDA to take into account an important legal distinction that FDA appears to ignore totally in the draft Guidance. That distinction is between “treatment of disease†and “therapies that may benefit.†In keeping with that distinction, explained below, it is suggested that the Guidance be titled, “Guidance for Industry on Complementary and Alternative Modality Products and Their Regulation by the Food and Drug Administration.†CAM is not “medicineâ€, does not rest in medical models and allopathic methods and does not seek to be considered “medicine.†In fact, CAM seeks to shed the appearance of “medicine†which is not in keeping with CAM traditions and activities. … The terms “treat†and “treatment of disease†are, in fact, antithetical to CAM therapies.
Then in what sense are they “therapies”? Well…
CAM health practices can be generally defined as traditional or other practices that are used by individuals, often for self-help, to achieve and maintain a healthy status, either on their own or complementary to standard medical care. These practices do not include the potentially dangerous use of invasive techniques and toxic drugs that are the sole province of licensed medicine. They do, however, include developing therapies and nonstandard approaches that are outside the scope of licensed medicine. Such approaches as Nutrition, Homeopathy, Hands-on-Healing, Magnetics, Sound Health, Energy Therapies, Biofeedback, Meditation, Breath Work, Reiki, Chi Gong, Tai Chi and Herbology are examples of complementary and alternative therapeutic practices. Traditional Chinese, Ayurvedic medicine or folk remedies and “Dr. Mom” home remedies are also examples of CAM practices. These practices aim, in the words of the late Philip J. Hodes, PhD., at “more efficient physiological integration and function of the human organism, leading to optimal wellness.” This definition is the polar opposite of non CAM practices which seek to suppress or ameliorate symptoms without an approach to optimal wellness.
You see, here, Major Stubblebine (hoho) is saying that–
Well, we’ll get on to that later. First let me point out that he is so certifiably insane he’s actually capitalising “nutrition”, listing it as an alternative “modality”, and then stands it along side such gibberish as Reiki, homeopathy, and “magnetics“. Nutrition is a science, not some piece of hokum quackery. It’s only weirdos like Patrick Holford and “Dr” Gillian McKieth who try to capitalise (on) it.
Now, where was I? Ah, yes. His point, it appears, if we leave aside the fact that every single “modality” he lists is patent rubbish or a bizarre pseudo-magical ‘formalisation’ of some well-established scientific principle (such as “eat well” or “breathe”), is that CAM is not designed to cure disease but to just make you more “well” in some kind of wishy-washy general sense. There are two problems with this. The first is that “optimal wellness” isn’t a thing. It doesn’t exist. It’s just a couple of words, one of which is practically made up and the other of which is effectively a truism, strung together to create the illusion of meaning. (I think it was Scott Adams who defined it as “the slowest possible rate at which you can die”.) In fact, pretty much the whole of Hodes’ quotation is gibberish. The second problem is that these therapies don’t promote anything like “optimal wellness”. Magnetics do nothing. Homeopathy does nothing. Biofeedback is a made up word. Energy Therapies are pure pseudoscience. Some of them are even damaging.
But the biggest problem is that “promoting optimal wellness” is still a measurable claim. I can quite easily design a test to examine it. You take a group of people, and divide them into groups. Give each group a different “modality” of “therapy”, some CAM and some conventional, such as sound dietry advice (which is different to “Nutrition” in that ‘dietician’ is a protected title and to call yourself one requires a qualification, whereas anyone can call themselves a ‘nutritionist’ with no fear of legal recourse) or some decent exercise, then you test them and see whose health improved most. We can measure health in a number of ways, and should use as many as possible for this experiment. That would, if your claims are true, validate them and then FDA would leave you alone. This remains true whether you choose to call it a “treatment” or a “therapy”.
We have analyzed the word “therapy†and the similar word “therapeutic†because these words are not forbidden by DSHEA and are referenced by the AMA Ethics Code. We recommend “Therapeutic Nutritionals†for alternative practices centered on Nutrition. We recommend the use of the qualifying word, “Nutritional†in this context to make it completely clear that the practitioner is not offering “treatment of disease.â€
You see, again, this is what I mean. Regardless of legal standpoint, if you heard the phrase “therapeutic nutritionals”, what would you think? Let’s assume for now that you are sufficiently naïve to think that whatever it is, it’s a legitimate practice. Personally, I would see the word “therapeutic” and equate that with some kind of medical treatment. Then I would see the word “nutrition” and equate that to diet. It looks like they’re promising to make me less ill by changing my diet. That’s science, then, surely?
No. Because the claim is that because in law the science of food is referred to as “diet” and not “nutrition”, and the curing or controlling of disease is referred to as “treatment” rather than “therapy”, any other words they might use to describe it are fair game. FDA, on the other hand, consider that anything marketed as providing health benefits must provide health benefits. I agree with FDA, because they’re right.
This next paragraph is important, I think:
The claims made for Therapeutic Nutritionals must, of course, be allowed Structure and Function Claims. Thus, for example, under current law as interpreted by the FDA, one cannot claim that a nutrient lowers cholesterol levels – since there is now a “disease†of hypercholesterolemia – but can claim that a nutrient maintains normal cholesterol levels for persons with normal cholesterol. A purveyor may say that a certain combination of multivitamins was designed to maintain normal structure and function for a person with diabetes, but not that the combination “treats†diabetes or affects the blood sugar level. Similarly, any Health Claim made for any alternative practice must meet the FTC standard of “truthful and not misleading” and must be based on standard commercial substantiation criteria.
CAM products are intended to benefit normal structure and function and are not prescribed as treatment for medical or psychological conditions, nor for diagnosis, care, treatment or rehabilitation of individuals, nor to apply medical, mental health or human development principles.â€
So his theory now is that if you’re saying “I can cure a disease” then by all means FDA should intervene and make sure you actually can, but if you’re saying “I can prevent a disease” then FDA should back off. This is interesting, and probably the result of the fact that Stubblebine (haha) doesn’t work in CAM. CAM is a huge industry with two markets. The larger market is healthy people, but the smaller market of people with incurable diseases is far easier to sell to — presumably this is why “Dr” Rath hates him so much.
As the High Court said in Thompson, “We have previously rejected the notion that the Government has an interest in preventing the dissemination of truthful commercial information in order to prevent members of the public from making bad decisions with the information. * * * Even if the Government did argue that it had an interest in preventing misleading advertisements, this interest could be satisfied by the far less restrictive alternative of requiring … a warning…”
What is the proper level of substantiation for CAM nutrient or health claims? It is not the “significant scientific agreement” required of drug claims, but rather, the general “competent scientific evidence” standard that applies to all commercial claims. That does not imply that purveyors need to have multiple double-blind experiments (as may be required for drug approval). Substantiation merely needs to be competent and scientific. We urge this to include research studies (which is when scientists review the work of others and apply it to specific questions) and clinical trials (which may be as formal as double-blind, placebo controlled investigations but need not be, since multiple variables, like those involved in CAM practices designed to promote optimal health, are not well studied by double-blind, placebo controlled investigations) as well as traditional knowledge, clinical case studies, observational reports and clinical experience. All of these sources of information and experience have a role to play, but ultimately, such substantiation must rest on the informed professional opinion of some credentialed or appropriately experienced person who can (in the case of Dietary Supplements, for example) sign onto the Structure and Function Claims Notice to the FDA, attesting that “the notifying firm has substantiation that the Statement to which this Notice applies is truthful and not misleading.” (Regulations under 21 U.S.C. 403(r) (6)).
The Natural Solutions Foundation favors a market approach to these issues and urges the FDA to reduce regulation to those minimum levels that will encourage the continued rapid development of CAM approaches. Especially when dealing with Dietary Supplements and Traditional Remedies, we are dealing with foods which, as foods, are presumed to be safe. There is no need for the high level of regulation that is required for the dangerous and invasive drugs and techniques of so-called “standard†medicine. Even with this stringent level of oversight, drugs are a major cause of death in every developed country while CAM remedies are an insignificant-to-absent cause of death world-wide. Rather, this is a situation where the public is best served by a policy of Laissez-Faire: allow CAM to develop freely in the public interest.
This is a very confusing bit of writing to me. He appears to be confusing two very distinct arguments: first, that CAM isn’t really medicine and shouldn’t be subject to the strict checks medicine is (”What is the proper level of substantiation for CAM nutrient or health claims? It is not the “significant scientific agreement” required of drug claims, but rather, the general “competent scientific evidence” standard that applies to all commercial claims.”), and secondly that conventional medicine isn’t really that good either (”…the dangerous and invasive drugs and techniques of so-called “standard†medicine. Even with this stringent level of oversight, drugs are a major cause of death in every developed country while CAM remedies are an insignificant-to-absent cause of death world-wide”). These are surely almost mutually exclusive arguments? If conventional medicine isn’t that great, then surely it would be easy for CAM to pass its tests, and if CAM isn’t medicine, then why attack medicine at all? I mean, car accidents are a significant cause of death in developed countries. Is that relevant?
In fact, you could construct these distinct claims into one coherent argument if you said “conventional medicine, for all its achievements, is generally a last-ditch effort to recover once you are already ill, whereas our aim is to prevent the illness to begin with by keeping you healthy. Ill people are in a vulnerable state and anything they do to their bodies to recover should be thoroughly tested, whereas healthy people require less strict controls as their bodies are in a position to fight back against any potentially harmful side effects”. This argument, though, is still flawed, because you are still making a lot of money selling things of unproven worth to people by claiming they are effective, quite without evidence.
If you say your product can help maintain a healthy cholesterol level, then you should be expected to prove it.
“The state has not restricted the cure of the body to the practice of medicine and surgery — allopathy, as it is termed, — nor required that, before anyone can be treated for any bodily ill, the physician must have acquired a competent knowledge of allopathy and be licensed by those skilled therein. To do that would be to limit progress by establishing allopathy as the state system of healing, and forbidding all others. This would be as foreign to our system as a state church for the cure of souls. All the state has done has been to enact that, when one wished to practice medicine or surgery, he must, as a protection to the public [not to the doctor], be examined and licensed by those skilled in surgery and medicine. To restrict all healing to that one kind — to allopathy, excluding homeopathy, osteopathy, and all other treatments — might be a protection to doctors in surgery and medicine; but that is not the object of the act, and might make it unconstitutional, because creating a monopoly.” North Carolina’s Supreme Court in State v MacKinght, 42 S.E. 580, 1902 at p 582.
“Because creating a monopoly”? That’s gibberish — I expect Supreme Courts to have a better grasp of grammar than that. This is supposed to be legally binding precedent! It has to make sense or what use is it?
Anyway, the point is that the latest FDA guidance document is exactly inkeeping with the spirit of what the court said — they have “not restricted the cure of the body to … allopathy”; they have specifically drawn no distinction between “allopathy, … homeopathy, osteopathy, and all other treatments”. You can’t discriminate against something without first recognising that it is different.
Costs, safety and, most of all, liberty, require that the distinction be made and maintained by the FDA between “treatment†and “therapy†if the US Constitution and public are to be served.
Your liberty to be scammed out of money is all that is at stake here. Relinquish it with glee.
