Orac on why "PatientsLikeMe" is a bad idea

Orac on why "PatientsLikeMe" is a bad idea

Orac on Homeopathy and Clinical Trials

Orac on Homeopathy and Clinical Trials:

So ridiculous is homeopathy that I sometimes feel that I and my fellow skeptics are firing Howitzers at an ant when we take so much time and effort to explain why homeopathy is nonsense. On the other hand, it is homeopathy's monumental lack of scientific plausibility that makes it a perfect teaching tool to explain the difference between science-based medicine (SBM) and evidence-based medicine (EBM). Specifically, because clinical trials have unavoidable shortcomings and biases, even at a p=0.05, which would imply only approximately a 5% chance that a given trial's apparently positive results could be due to random chance alone. As John Ioannidis has taught us, in clinical trials as practiced in the real world, the chance is much higher that any given positive trial is a false positive. It also means that, the lower the prior plausibility of a remedy working, the higher the chance of false positive trials. This is exactly what we see in homeopathy, hence the panoply of homeopathy trials showing "positive" results in which the treatment group is barely different from the control and/or the results barely reach statistical significance. With something like homeopathy, which violates the laws of so many sciences, it is relatively easy to make the case that it takes a lot more than a few equivocal clinical trials to show that so much well-established science is wrong. Apparently positive clinical trials of homeopathy are measuring, in essence, the noise inherent in doing clinical trials.

Quack Diagnostic Criteria (QDC)

This document represent an unfinished attempt to collect criteria for the diagnose of quacks. I had most of it done a couple of weeks ago, but I don't have the energy to properly finish it. So here it is, unfinished work in progress, to be refined over time:

The Quack Diagnostic Criteria (QDC)

As a simple definition, a quack is someone:

• who practices medicine (tries to treat diseases/illnesses/ailments/etc.)
• and postulates disease theories and treatment mechanisms which are not rooted in reality
• and does provide no actual evidence for his disease concepts

To differentiate, someone postulating a hypothesis to be tested – while making clear that it is only a unproven hypothesis – is not a quack.

As well, someone treating people while aware of the insufficiency of the available information, and communicating this fact clearly, is not a quack either.

And, for our definition, a quack shall not be someone who provides knowingly faulty evidence for disease theories and treatment mechanisms, because, in contrast to a quack, someone providing knowingly faulty evidence is a fraud. However not all frauds know that they lie: some frauds delude themselves and think – just like quacks – that they are right. The distinction between a fraud and a quack is a difficult one, as we can't look into someones head.

And someone providing unknowingly faulty evidence (e.g. gathered by other people) is a fool (at best), but might be a quack as well.

Please note: Not every unscientific doctor is a quack! A quite distinct subgroup of unscientific doctors can be well characterized as "psychiatrist" or "psychologists". Same as in the quack discipline of Ostheopathy there are tendencies for reformation and adherence to scientific principles (cf. Evolutionary Psychology), but until today these are far from sufficent.

The typical quack is a loner. He or she is in most cases only loosely associated with a few select other quacks, unlike the organized quackeries of psychiatry, chiropractic "medicine" and (the unreformed) Ostheopathy. Yet conversely, most of the people a quack associates with are quacks as well.

One problem in diagnosing quacks is that they tend to "borrow" terms form proper medicine for their purposes. They may seemingly talk about "allergies" or "toxins", yet when quacks use terms like these they remain vague with their assertions. So one doctor says "allergy" and means an concrete pathological process, which can be tested for with proper tests – and another doctor says "allergy" and means this and that, and uses tests that are not worth the postage paid for them (if doctor does test at all).

Another problem is that an – otherwise reasonable – doctor may fall victim to the trends of our time and include one or two methods that should be avoided. The difference between a reasonable doctor and an quack usually is the amount of BS, woo and quackery included. An otherwise reasonable doctor may for example resort to acupuncture, because he does not know better. If a doctor however prominently advertises woo – e.g. the holy trinity of quackery: homoeopathy, acupuncture and holistic naturopathy – he usually is an quack.

And as a corollary, the quality of the total argument by the doctor should help to differentiate quacks from proper medical doctors.

Following are four areas, where one can rate someone if he/she is a quack.

What a Quack says about his/her field:
Add a point for each one applicable, add additional points for each asterisk (*).

Dislikes "Western" Medicine
Tries to "integrate" BS into Medicine *
Never talks about Evidence Based Medicine
Or, tries to give medicine based on actual evidence a bad name (What's the alternative? "Believe Based Medicine"?)
Adherent of "Traditional" Medicine (Chinese, Indian, Whatever) **
Adherent of Ayurveda **
Adherent of "Alternative" Medicine **
Adherent of "Complementary" Medicine **
Adherent of "Integrative" Medicine **
Adherent of "Naturopathic" Medicine **
Adherent of "Functional" Medicine **
Adherent of "Holistic" Medicine (whatever that is) *
Adherent of "Environmental" Medicine
Adherent of "Nutritional" Medicine *
Adherent of Herbalism **
Adherent of "Neuro-Immune" Medicine *
Adherent of mind-body dualism **
Adherent of Chiropractic "Medicine" **
Adherent of Osteopathic "Medicine" **
Adherent of Aromatherapy *
Talks about "Allopathic Medicine" **
Seeks the company of other quacks **
Sees drug companies as the root of all evil
Others are doing it for the money! (while ignoring his/her own financial interests)
Sees "The Establishment" as the root of all evil

The method a quack uses:
These are the methods used (or not used) by the individual to be tested for quack tendencies.

Displays displeasure towards the scientific method *
Never talks about "regression toward the mean"
Does studies that are not reproducible *
Likes non-blinded studies **
Likes studies without proper control groups
Likes studies with very small sample sizes
Likes case studies *
Loves anecdotes *
Loves tests without diagnostic value **
Loves speculation without evidence **
Ignores studies that contradict his speculations *
Likes weasel-words *

What a quack says about disease causes or mechanisms:

Speculates about disease mechanisms without evidence *
Speculates about undetectable persistent pathogens *
It is unmeasurable "chronic low grade" or "persistent" infections! **
It's an allergy!
It's the mitochondria!
It's vaccines! **
It's Lyme! **
It's XMRV! **
It's HIV-negative AIDS! **
It's mold! **
It's candida/yeast! **
It's heavy metals! **
It's mercury! ***
It's "toxins"! (Generally unspecified "toxins") *
It's pesticides!
It's radiation/electrosmog/microwaves! *
It's electromagnetic field (EMF) hypersensitivity (EHS)! *
It's inflammation!
It's free radicals!
It's oxidative stress!
It's the amygdala! **
It's the hypothalamus! **
It's the neuro-transmitters! *
It's the endocrine system / hormones!
It's the adrenals! *
It's the thyroid! *
It's thyroid hormone resistance! **
It's metabolism blockage! *
It's Th1/Th2 immune imbalance! **
It's the acid/base balance! It's too much / too little acid! It's too much / too little bases! **
It's energy blockage! **
It's (bio-)energy! **
It's vibrations! **
It's malabsorption!
It's the gut!
It's an leaky gut!
It's the subconscious! *
It's qi! **
It's "balance" (or lack thereof)! **
It's "harmony" (or lack thereof)! **
It's "dysfunction"! **
It's some other newfound fancy mumbo-jumbo! (e.g. Gene Instability)

What a quack prescribes:

Again, add a point for each. Add another point for each asterisk (*).

Recommends vitamin supplements
Recommends mineral supplements
Recommends magnesium supplements
Recommends trace element supplements
Recommends enzyme supplements
Recommends protein supplements
Recommends probiotic supplements
Recommends micronutrient supplements
Recommends anti-oxidant supplements
Recommends daily intake of OTC drugs like aspirin or NAC
Recommends "natural" remedies *
Recommends herbs and plant extracts *
Recommends homeopathy **
Recommends acupuncture **
Recommends reflexology **
Recommends fire cupping **
Recommends reiki ***
Recommends biofeedback/neurofeedback ***
Recommends neuro-linguistic programming (NLP) ***
Recommends hypnotherapy
Recommends "emotional healing" **
Recommends oxygen (e.g. hyperbaric oxygen therapy HBOT)
Recommends "desensitisation"
Recommends long-term anti-biotics **
Recommends GcMAF
Recommends "detoxification" **
Recommends "chelation" **
Recommends something with a "Detox Reaction" ***
Recommends something with "Die-off or Herx/Herxheimer reactions" ***
Recommends expensive tests not covered by insurance, available only at special labs *
Has an proprietary treatment "protocol" **
Has an "one size fits all" treatment protocol **
The treatment "protocol" is an erratic collection of woo**
Has an extensive treatment protocol were he/she throws everything but the kitchen sink at a patient
Call his protocol "individualized" medicine despite his/her "one size fits all" approach **
Claims to have a better cancer treatment than evidence based medicine **
Claims to cure cancer **
Claims to cure autism **
Talks about "healing" outside the context of flesh wounds
Talks about "mobilizing the body's healing capacity" or some such
Sells any of the above **
Can't be bothered to recommend something that has been tested, because testing if something actually helps (or harms) people would be "too expensive"

Closing remarks

The higher the score, the more likely you are dealing with a quack – again, some of these talking points might be used by real medical doctors. The score-values for each area will have to be determined empirically. If someone's talking points are more than 80% from this QDC, you can be certain to have a quack.

And unfortunately, if someone is not a quack, that does not make him/her necessarily an good medical doctor…

Dr. Sarah Myhill, I presume

This piece article was posted on ProHealth.com, supposedly by Dr. Sarah Myhill. I can only presume it is meant as a parody of a quack, as it does not supply any evidence for its numerous claims – the only shred of evidence revolves around "Mitochondrial Dysfunction", which is only mentioned in passing at the beginning and is furthermore not central to any of the theories presented. As it seems to be a parody, I will take the liberty to answer with a few sarcastic remarks.

Dr. Myhill’s notes on fatigue, the immune system’s energy demands, and Rituximab
ProHealth.com
by Dr. Sarah Myhill, MD*
February 17, 2012

Dr. Sarah Myhill is a UK-based physician with a special interest in nutrition and fatigue. Her pioneering research (“Chronic Fatigue Syndrome and Mitochondrial Dysfunction”) suggests the cells’ energy generating mitochondria are dysfunctional in chronic fatigue syndrome (ME/CFS) and other 'neuro-immune' illnesses. This article is excerpted with kind permission from Dr. Myhill’s educational website (DrMyhill.co.uk).*

_________________________

Energy Expenditure in ME/CFS: Immune Wastage of Energy and Rituximab

…

In ME/CFS either that pot of energy can be small (because of poor mitochondrial function, poor fuel supply, poor adrenal function, poor thyroid function and so on), or we can be spending energy wastefully.

How about we throw in some more human organs (the "and so on") without supplying evidence? OK, here we go: In ME/CFS either that pot of energy can be small (because of poor mitochondrial function, poor fuel supply, poor adrenal function, poor thyroid function, poor liver function, poor muscle function, poor brain function, poor skin function, poor bladder function, poor bone function and so on).

…
However, I suspect a greatly overlooked cause of wasting of energy is immunological.

If Dr. Myhill has any evidence for this, why does she keep it for herself?

Energy must be expended on daily "house keeping" duties. I was intrigued to see the following energy expenditure breakdown in Wikipedia:

- Liver 27%,
- Brain 19%,
- Heart 7%,
- Kidneys 10%,
- Skeletal muscle 18%,
- Other organs 19%.
It astonished me that the liver consumes more energy than the heart and brain combined! Much of this has to do with assimilating and detoxing food from the gut!

 Or simply it's the role the liver has in carbohydrate metabolism (among other).

Immunological Energy

I see the immune system to be like the brain, i.e. it is enormously demanding of energy. We all know this - if a healthy person develops influenza, then he becomes bed-bound for two weeks (she becomes bed-bound for a week….!).

Work done by Caroline Pond has demonstrated that when wild animals put on weight, the first place they dump their fat resources is around lymph nodes; i.e., the immune system.

Oh, that's were the extra Kilogramms went! Doh! To my lymph-nodes! Especially the lymp-node at my stomach! How stupid of me. Must be all the toxins from my gut.

Bone marrow, of course, is very fatty, so this suggests the immune system is not just demanding of energy, but energy in an intensive form; i.e., fats and oils.

The immune system spends energy fighting infection, which is, of course, highly desirable. However, if it gets its wires crossed, it may end up fighting the body itself (autoimmunity), or fighting substances which do not cause harm, and this is allergy.

Here we have the best explanaition of autoimmunity of, like, ever: Crossed wires! And we all know what happens when wires are crossed: The battery goes flat in no time. So the next time your car won't start, you know it is an allergy.

However, in ME I suspect there is another immunological waste of energy which has to do with microbes, possibly “allergy” to microbes.

So the "immunologic waste of energy" Dr. Myhill postulated without evidence was just a decoy? WTF?! "Allergy" to microbes?

Post-Infectious ME

Here, Dr. Myhill crosses her wires. Or her terms. I don't know.

A great many cases of ME follow viral infection and/or vaccination. In these conditions the immune system is switched on to fight the offending microbe.

And there is great evidence that Dr. Myhill is stupid and/or uses weasel words. And if there is an "offending microbe", why doesn't Dr. Myhill test for it and treat it?

In the short term this is highly desirable. To be effective, all vaccinations contain immune adjuvants which are there specifically to fire up the immune system. When this works in our favor, we call it immunity.

And when vaccines work, Dr. Myhill will fight this because she is anti-vax.

However, when it works against us, we call it allergy. Clinically, we know that vaccinations can trigger allergies.

Yet, Dr. Myhill fails to mention the most serious disease that is caused by vaccines: Antivaccinitis Stupidis, or stupid anti-vaxxer syndrome. And for anti-vaxxers "we know" seems to be some evidence surrogate.

And what's with her allergy fetish? Can Dr. Myhill ever stop thinking of allergies? And is that a sign that Dr. Myhill has an allergy to the scientific method? Inquiring minds want to know!

There is no doubt that there are some ME patients who do not recover until they start taking antivirals (see work by Dr. Martin Lerner in my page "Valacyclovir in the treatment of post viral fatigue syndrome,” Sep 2010), antibiotics or antifungals.

Would antiquacks help too? As I would guess there is more evidence of quack involvement, and I have not seen evidence from Dr. Myhill that viruses, microbes or fungi(!) are involved.

 In these cases, there is often no overt evidence of infection.

What, wait. No evidence! No shit, sherlock! No evidence. I am puzzled. So Dr. Myhill bases her case on her rampant imagination?

I suspect what is going on here is that these microbes are present in low levels which would not normally cause harm to the body, but the immune system continues to fight.

And I suspect Dr. Myhill throws around all kinds of fancy terms and evidences-less theories to impress people. No, that can't be!

It is a sort of inappropriate immune activation against microbes or “allergy” to microbes. This is hugely wasteful of energy. Such patients will have a large immunological hole draining their daily energy bucket.

"Allergy". To Microbes. An "allergy" to microbes. And "allergy", with quotation marks. I can hear Robert Koch spinning at the RKI.

Immune Mapping

Immune Mapping?

What we perceive going on in the body is not what is really going on in the body, but it is what the brain tells us is going on in the body!

And the same goes for Dr. Myhills "explanations" about ME/CFS – she does not tell us what is really going on in this illness. I'd say she hasn't got a clue but spinning lots of evidence-less theories – but who am I to tell?

The brain has a complete map of the body, which includes sensory and motor functions. Ref “Phantom Limb Syndrome” by Dr. VS Ramachandran (University of California, San Diego).

It is possible that this could explain the mechanism by which healing and touch therapies such as Bowen therapy, Reiki, Kinesiology, etc. work. These techniques are literally re-mapping the brain to perceive things quickly, or direct motor actions correctly.

It is possible that the immune system has a similar mapping process.

And it is possible that Nazis are living on the far side of the moon – don't ask me for my non-existent evidence, and I won't ask Dr. Myhill for her non-existent evidence, OKAY?

I think of the immune system as having a “map” of what should and should not be present in the body. I imagine it “sniffing” about the place looking for foreigners.

And I think of Dr. Myhill as someone talking out of her arse. The immune system having a "map". Yeah, Dr. Galileo Galilei Myhill, misjudged and unrecognized medical genius, creator of medical theories without a shred of evidence.

There are many good doctors who have experimented with many different types of immunotherapy, such as neutralization, enzyme potentiated desensitization (EPD) and, of course, homeopathy; and it may well be that they are having their beneficial effects because of this re-mapping of the immune system.

"Good" doctor and "experimented with homeopathy" in the same sentence. My irony meter, broketh it hath.

All these mechanisms are characterized by extremely low levels of molecules or antigens being applied with profound effects that cannot be explained by conventional pharmacology.

And that cannot be explained by any evidence from Dr. Myhill.

You, Milady Myhill, are full of shite.

Treatment of Badly Educated B Lymphocytes

"Badly educated" B-cells? What in the name of Darwin?

Immune mapping probably takes place in B lymphocytes. They start life in the bone marrow, move into the blood stream, and are educated by the thymus gland and lymph nodes. This takes a few months. The mature B lymphocytes become the decision makers for immune attack or immune tolerance (war or peace!).

More like "Idiocy or Madness!"

Post infectious ME patients may have B lymphocytes constantly at war. These white cells have been badly educated, their wires are crossed.

Plus, ME patients may have doctors that are constantly talking out of their arse. These doctors have been badly educated, their wires are crossed – it happens.

This therefore gives us a model for treatment.

A model for treatment that solely exist in the head of the good Dr. Myhill.

Either we can re-educate these B lymphocytes or we can kill them, or we can try to reduce the things they are inappropriately reacting against, which may be foods (diet) or microbes (with antimicrobials which could be drug or herbal, change the gut flora with probiotics).

Cultural Revolution and Re-Education for B-cell lymphocytes!

Re-educate B Lymphocytes with Immunotherapy

Perhaps desensitization with neutralization, EPD or homeopathy are techniques directed at re-educating these B lymphocytes to respond appropriately by remapping the immune system?

Or perhaps the good quack doctor will respond to some re-education? Nah.

In the case of neutralization the result may be immediate. With EPD (and I know much more about this because I have been using EPD for 25 years!) the result is often delayed by a few months, it lasts weeks to months, and then patients may need a top up of the treatment.

And I know much more about Dr. Myhill because I have been spending 15 minutes with this dreck.

Although these desensitizations are largely directed at foods, inhalants and chemicals, some microbial antigens are also included. See “Enzyme Potentiated Desensitisation (EPD) - how it works".

See also "Evidence – how not to provide any".

Kill B Lymphocytes with Rituximab

This drug is a monoclonal antibody specifically effective against the CD20 receptor on B lymphocytes. It specifically depletes B lymphocytes; i.e., it kills off the standing army – if this army is involved in civil war, then its depletion is a very desirable action!

And Maoism is Constant Struggle!

Rituximab is primarily used in cancer chemotherapy. By pure chance a patient who had severe ME received this drug as part of a treatment for her lymphoma and her ME symptoms disappeared. She was delighted! Her daily energy bucket was no longer being immunologically drained!

This prompted a study by her Norwegian oncologists, Prof Olag Mella and Dr. Oystein Fluge at Haukeland University Hospital, Bergen, to conduct a placebo controlled double blind trial into the effectiveness of Rituximab in ME.

This was done with 15 patients receiving the active preparation and 15 the placebo… [See “Benefit from B-Lymphocyte Depletion Using the Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome: A Double-Blind and Placebo-Controlled Study.”] Rituximab had a highly significant beneficial effect.

What was so interesting about this effect is that it took 2 to 4 months to start, it lasted for 2 to 6 months, then some patients relapsed but some were cured!

This fits very nicely with the time scales I see in my EPD patients – again there is a delayed start, improvement, then top ups required according to the clinical response.

And this fits very nicely with my theory that Dr. Myhill simply has no idea what she is talking about and is just throwing around fancy terms.

Another way to tackle this problem of inappropriate activation against microbes would be to use therapeutic agents which may be herbal, or prescription medication, to try to reduce the level of microbes so much that the immune system stops reacting.

Herbs to the rescue! How fitting, that she does not know what she exactly fights, but she fights it with herbs about which she does not know whether they work, at all, let me repeat does not know whether they work AT ALL, against anything.

It may be that this approach explains the success of Dr. Martin Lerner’s work with antivirals, treatments with antibiotics for Lyme disease, and with antifungals for chronic yeast problems.

Or it may be that Dr. Myhill talks out of her arse. I'm still not sure.

It is the old story - we have a lot more good questions than good answers, but at least we are asking the right questions!

Yes, it is the old story! You, Milady Myhill, are not asking any good questions, you are simply and carelessly providing bad answers in the form of unsubstantiated theories.

I, for one, am thankful for this satire posted by ProHealth.com and the opportunity to return this gift with a few sarcastical words of mine.

WPI's World of Woo – why anything from the WPI is suspect (2)

Cyrus Pourzan, M.D., H.M.D.
http://www.facebook.com/photo.php?fbid=10150613855074672&set=a.10150613854979672.407782.154801179671&type=3&permPage=1

Dr. Cyrus Pourzan is a rare find in the medical community. He is a Board Certified medical physician with a passion to find "medicine that works." [but does not seem to be passionate that the "medicine that works" was actually properly tested in clinical trials] In his practice, he combines his experience and knowledge of Western medicine with alternative therapies and natural medicines [for which no evidence of efficiency or safety exists – otherwise it would be called evidence-based medicine]. This allows him to tailor treatments to the individual. For the past 12 years of his 31 year medical career, he has been treating patients with neuro-immune disease and brings this experience to the Center for Translational Medicine.

Dr. Pourzan obtained his medical degree from the University of Cincinnati and went on to complete a residency at UCLA in Emergency Medicine. He has been Board Certified in Emergency Medicine since 1984. Aware of the limitations of Western medicine, he began to expand his education into complementary and alternative therapies [for which no evidence of efficiency or safety exists – otherwise it would be called evidence-based medicine]. He pursued this path by obtaining additional licensure in homeopathic medicine and medical acupuncture (UCLA) in 2002.

Living in the Reno-Tahoe region has provided Dr. Pourzan with the opportunity to work with some of the most eminent authorities in the fields of neuro-immune disorders, bio-identical hormone replacement, auricular acupuncture, and pain management. His current field of interest is the role of oxidative stress in illness. He finds [What? He "finds"? What a weasel word. Apparently he does not have evidence] that a balance between modern medicine and traditional therapies can successfully treat the cause of his patients' illnesses.

Dr. Pourzan's medical mission is to help people achieve the best quality of life. In his spare time, he likes to be outdoors cycling, hiking and skiing. He also enjoys music and art. His new practice location is the best of all worlds. It is an ideal environment for both his professional and personal pursuits.

The Center for Translational Medicine is proud to announce that Dr. Pourzan is now seeing patients.

"The plural of anecdote is not data and even the most intuitively obvious medical beliefs must be tested"

The German philosopher Hegel said, “We learn from history that we don’t learn from history.” “Homeopathy and Its Kindred Delusions” is a remarkable little book based on two lectures Oliver Wendell Holmes gave in 1842. It is a masterful debunking of homeopathy. If his lessons had been taken to heart, homeopathy would not have survived and we could have avoided a great number of other medical delusions that continue to plague us today, both from charlatans and from well-meaning advocates who lack Holmes’ critical thinking skills.

To realize just how remarkable this book is, imagine the world of 1842. Samuel Hahnemann, the inventor of homeopathy, was still alive. Roentgen wouldn’t discover x-rays until 1895. The germ theory was not yet established. Semmelweis wouldn’t make his observations on puerperal fever until 3 years later. It wasn’t until 1854 that John Snow removed the Broad Street pump handle and stopped a cholera epidemic. Koch’s postulates for determining infectious causes of disease weren’t published until 1890. Doctors didn’t wash their hands or use sterile precautions for surgery. Bloodletting to “balance the humors“ was still a common practice. The randomized placebo-controlled trial wouldn’t appear for another century. Contemporary medicine often did more harm than good. In fact, Holmes himself famously quipped “I firmly believe that if the whole materia medica could be sunk to the bottom of the sea, it would be all the better for mankind and all the worse for the fishes.”

Oliver Wendell Holmes did not have any of the advantages of modern medical science, but he did have a good brain and knew how to use it. He begins by saying that stories of cures are of little value because of the fluctuations of disease and the fallacies of observation, a lesson that today’s proponents of questionable treatments have yet to learn. We are constantly having to tell them that the plural of anecdote is not data and that even the most intuitively obvious medical beliefs must be tested. Holmes points out that ineffective treatments commonly appear to benefit patients through an influence on their imaginations, but advocating them is as deceptive and unethical as passing counterfeit money.

In his first lecture, Holmes reviews four nonsensical treatments to illustrate “the fallacy of popular belief and the uncertainty of asserted facts in medical experience.” The kings of England used to touch people by the thousands to cure scrofula, the weapon ointment was applied to weapons to heal the wounds they had caused, the estimable Bishop Berkeley promoted tar-water as a panacea for everything from smallpox to asthma, and patients were stroked with metallic rods, Perkins’ tractors, to relieve a variety of symptoms. These delusions were widely accepted over varying periods of time by the public, by respected clergymen, and even by doctors.

There is only one medicine – medicine proven to work

Everything else is snake oil.

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.

On Dealing with Shruggies

As I read through this new volume of content I found it to be poorly written and journalistically weak – and the subject matter of article after article was unfamiliar to me. Colon cleansing, liver flushes, systemic yeast overgrowth, energy healing – it all sounded far-fetched, and so flawed as to be almost humorous. It was utter pseudoscience – full of silly jargon and implausible “mechanisms of action” that defied what I knew of pathophysiology and even basic chemistry and physics. I looked around to see if I was on Candid Camera – but alas, it was not a joke.

So I began researching these subjects in the medical literature to try to make sense of the content. I sought input from medical experts whom I trusted – I interviewed gastroenterologists, infectious disease specialists and even one of the world’s leading hepatologists. They all confirmed that these treatments and conditions had no scientific basis whatsoever, yet they were being widely promoted in the “natural health” world.

Still reeling from the bizarre nature of this new pseudo-scientific babble, and utterly convinced that promoting false information to patients was unethical, I told John that I simply couldn’t approve any of these articles for publication. John protested that I was “putting a gag order on content” and that he’d do whatever it took to go around me to promote his pro-CAM agenda. He went on to call me “a racist against CAM…a dinosaur, part of a dying breed of physician… and paternalistic and narrow.”

Nazi Science Sneers at Complementary and Alternative Medicine

First, I have to explain the title: It comes from the webcomic called "Irregular Webcomic". It is always used as a plot device when the Nazis in the comic have figured out to do something impossible like overcoming the boundary between life and death or aerodynamic implausibility. Oh what wacky fun ze Nazis are!

Cut to real life. The actual scientific inquest of the german fascists isn't so far away from this, albeit a lot more idiotic and barbaric. The fascists usually started from some pseudoscientific non-sense bullshit and tried to prove it (cf Josef Mengele). Very seldom they were right – that is the case when you start with wacky pseudoscientific BS.

Part of the fascist BS believe was a variant of the "Nature is good" meme. While for religious groups this has its roots in the believe that everything in nature was created for us humans, the german fascists believed that they were the most adapted to nature, and therefore a "rooting" in nature was almost all they needed. It was some sort of pseudoscientific nature religion, with christian and nordic elements, if you want to put it that way.

The one thing they got right was smoking: They viewed smoking as against nature and I have it at good authority that the german fascist researchers were the first to prove that smoking causes cancer.

Falling squarly into "Nature is good" meme, the fascists did some research into herbal medicine. There wasn't much until the fascist germany surrendered in 1945, but research continued in west-germany. Until 1978,  when the "Commission E" was founded, over 300 herbal drug preparations have been cataloged. Until 1994, when the commission E was dissolved, the number rose to 380. In 1998, the commission E monograph were translated into english. The result? Apart from lacking the scientific rigor needed, there is little usable, maybe the list of disapproved herbal drugs being the exception. The era of Opium, Aspirin, Digitalis or Chinin had long gone, useful herbal substances are few and far between.

So if ze Nazis failed, maybe others will prevail? Today there seems to be some research in India, with its Ayurvedic tradition, and possible China with its Traditional Chinese Medicine. But both Ayurveda and TCM are deeply rooted in pseudoscientific concepts and the artificially designed substances stand a much bigger chance of having a desired spectrum of effects.

Nature is no magic bullet for our woes, but we sure could learn some more about the nutrition we had in evolutionary (pre-neolithic) times.

Scientific process: Useless treatments found to be useless (2)

Last month [August 2009], a major study whose results had been anticipated by the alt-med community, as well as those of us who consider it to be highly unethical pseudoscience, were reported. However, they were reported without fanfare, without press releases, without any sort of publicity whatsoever. Only a handful of bloggers who have paid attention to the issue (myself included) even noticed, and even I wouldn't have noticed if someone hadn't forwarded the journal article to me and asked me what I thought of it. So under the radar is this important paper that not a single alt-med website that I've been able to find has commented on it, even nearly four weeks after its release.

I wonder why.

I suspect that you'll soon understand why. The study is of an "alternative" medical therapy for pancreatic cancer, one of the most lethal, if not the most lethal, cancer there is. There are several reasons for the lethality of pancreatic cancer. …

Because the outlook for pancreatic cancer, particularly unresectable pancreatic cancer is so grim (the median survival has barely budged from less than six months for decades. Median survival for untreated metastatic pancreatic cancer is on the order of 3-4 months, although gemcitabine chemotherapy regimens combined with radiation) can result in median survivals of six months or more. For locally advanced pancreatic cancer that cannot be resected but has not metastasized, the median survival is on the order of 6-12 months depending on the study. Thus, we can rightly say that pancreatic cancer is one of those cancers for which science-based medicine has frustratingly little to offer that can cure it. That's not to say that science-based medicine doesn't have a lot to offer for palliation, but no one wants just palliation. We all want to live to a ripe old age, not just have our pain and nausea palliated for a few months before cancer claims us. Even scarier is that pancreatic cancer usually produces few or no symptoms until it is fairly advanced. Usual symptoms include vague upper abdominal discomfort, loss of appetite, and post-prandial nausea from intermittent gastric outlet obstruction, you know, the sorts of symptoms that nearly of us have from time to time and that primary care doctors see in their practice every day. By the time a pancreatic cancer causes severe pain or obstructs the bile duct leading to jaunice, it's usually unresectable or metastatic. (Often the reason it causes such severe pain is because it invades a plexus of nerves just posterior to the pancreas.)

It is the very deadliness of pancreatic cancer and the lack of effective life-saving or life-prolonging treatments for it that make pancreatic cancer a ripe condition for quackery. Rising above most other quackeries to attract a lot of attention about a decade ago is a quackery known as the Gonzalez protocol. It is described on Dr. Nicholas Gonzalez's website as involving dietary changes, supplements, the replenishment of pancreatic proteolytic enzymes, and "detoxification," including coffee enemas. It is not an easy therapy to undergo.

For example, Dr. Gonzalez states:

Overall, cancer patients will consume 130-175 capsules a day, including nutrients as well as enzymes. Non-cancer patients might consume in the range of 80-100 capsules a day, the exact number depending on their health status and medical problems.

I know of no science-based cancer protocol that requires a patient to consume 150 pills a day. There are also the dietary alterations that can be quite hard to follow, as well as the frequent coffee enemas. All in all, the Gonzalez protocol is an arduous regimen for a debilitated pancreatic cancer patient to follow. Still, for some reason, it gained some popularity in the "complementary and alternative medicine" (CAM) community, so much so that, based on poorly designed case series of eleven patients, Dr. Gonzalez managed to get a clinical trial funded by the NIH to study his method versus standard chemotherapy, a sordid story that Dr. Atwood has chronicled in detail in a long series of blog posts. That trial ended in 2005.

So why is it 2009 before we have the results of this trial, which show that the Gonzalez protocol is worse than useless? As Gollum would say, "It makes us wonder, yes it does." …

Sadly, the "scientific" rationale behind the Gonzalez protocol, with its megadoses of supplements and pancreatic enzymes plus "detoxification" by coffee enemas, is a perfect example of what Harriet Hall terms "Tooth Fairy science." The Gonzalez treatment is basically a modification of a protocol known as the Kelley Treatment, which in turn was very similar to the Gerson protocol. In any case, it's all an example of how alties have this conception that disease is caused by "toxins" and "contamination" that must somehow be purged in a religious ritual of colon cleansing. I've joked about this before as being an example of when mere regularity is not enough and mocking late night infomercials about colon cleanses, but, totally serious, Chabot writes in the introduction to this study:

The Scottish embryologist John Beard first proposed pancreatic proteolytic enzyme treatment in 1906 and soon after published a monograph, entitled The Enzyme Therapy of Cancer. In 1981, Nicholas Gonzalez began to evaluate the use of proteolytic enzyme therapy. Twelve years later, in 1993, he was invited to present a series of cases at the National Cancer Institute (NCI), which led him to undertake a case series of alternative medical therapy that included proteolytic enzymes, diet, nutritional supplements, and detoxification procedures. Among 11 patients with inoperable, biopsy-proven, stages II to IV pancreatic adenocarcinoma, he reported 81% survival at 1 year and 45% at 2 years. Four of the 11 patients survived for 3 years.

This is the very example of an implausible hypothesis. True, it's not as implausible as homeopathy (few hypotheses are), but it goes against everything we know about cancer in general and pancreatic cancer in particular. There is no evidence that pancreatic enzyme deficiency has anything to do with pancreatic cancer, for example. …

Here's the problem. These "toxins" are never identified, nor is there any evidence that the Gonzalez regimen actually removes them. It's not that environmental exposures don't have an effect on cancer susceptibility. Smoking can cause lung cancer and, ironically enough, increase the risk of pancreatic cancer as well. "Detoxification" quackery like the Gonzalez protocol takes science and turns it into Tooth Fairy science by giving near magical characteristics to these "toxins." In any case, cancer is primarily a genetic disease. Even heavy smokers who smoke for 50 years "only" have about a 25% lifetime risk of developing lung cancer, which means more smokers don't get lung cancer than do. In any case, think about it: Let's say there is this host of unnamed, undefined "toxins" that give you pancreatic cancer. Remember, the toxins from tobacco smoke that predispose to lung cancer are largely known and quantifiable. Why would one think that coffee enemas would remove those "toxins"? Certainly there is no scientific basis to think that the special diet, the dozens of capsules of supplements and pancreatic enzymes, or the other aspects of the regimen would "detoxify" anything. Basically, the Gonzalez protocol appears to derive from a prescientific notion of disease that is almost religious in its nature blaming "contamination" as the cause of all disease and that one must "purge oneself" of this "contamination" to cure the disease.

But, say Gonzalez supporters, what about the case series of 11 patients with stage II to IV pancreatic cancer from the 1990s reporting 81% survival at 1 year and 45% at 2 years, with 4 of the 11 patients surviving for 3 years? As Dr. Kimball Atwood pointed out, this was a nonconsecutive case series, a so-called "best case" series. Basically, it's a cherry-picked series, and I've criticized "best case" series before because they in essence intentionally look at outliers for whom the therapy may or may not have made a difference. …

So what was this trial? These were the objectives:

1. Compare the survival of patients with stage II, III, or IV adenocarcinoma of the pancreas treated with gemcitabine versus intensive proteolytic enzyme therapy and adjunctive dietary and nutritional support.
2. Compare the quality of life in patients treated with these regimens.

…
One serious problem with a nonrandomized design like this is the likelihood of selection bias. In this case, it would be "self-selection" bias in that investigators would have to worry whether patients who were either worse off or better off might opt preferentially for one arm of the trial over the other. I will address that point after we look at the results, which are quite striking:

In words:

At enrollment, the treatment groups had no statistically significant differences in patient characteristics, pathology, quality of life, or clinically meaningful laboratory values. … At 1 year, 56% of chemotherapy-group patients were alive, and 16% of enzyme-therapy patients were alive. The quality of life ratings were better in the chemotherapy group than in the enzyme-treated group (P <.01).

In all my years in medicine, surgery, and surgical oncology, I have never seen a study with such a striking difference in outcome between the two groups. No wonder the Office for Human Research Protections (OHRP) issued a determination letter stating that it was appropriate to terminate the study before the full 72 patients were enrolled due to the study having reached its "predetermined stopping point." These days, clinical trials are designed with periodic assessment of results and predetermined stopping points. These stopping points are invoked to shut down the trial in the event that one group is doing so significantly better than the other that enrolling the remaining patients could not possibly change the result. The purpose of such a stopping point is to protect clinical trial subjects from being enrolled in a study that no longer has clinical equipoise; i.e., the groups can no longer be predicted to have roughly equivalent outcomes based on what we know. Usually, it's the experimental group that does better than the control group. At least that's the intent. Sometimes, however, as in the case of the Gonzalez protocol, it's the experimental group that does much worse, so much so that the study has to be halted before reaching its full accrual.

But it's even worse than that.

Read it all!

The moral of the story: Even if evidence based science hasn't much to offer for your illness, you can be much worse off by trusting untested treatments.

… Given the striking difference between the two groups and the fact that the Gonzalez group did more poorly than historical controls, from this study we can confidently say that the Gonzalez protocol is almost certainly no better than no treatment.

In fact, it's probably worse. Go back to Dr. Atwood's post on this issue and consider the story of an unfortunate 40 year old man who enrolled in the trial and chose the Gonzalez protocol arm. This man was told to have his fillings removed and afterward tried as hard as he could to continue the regimen to the letter and suffered horribly as he did. At one point he was even told that increasing pain might be an indication that his tumors were "dissolving."

Oh, this reminds me of the "die off" myths with regards to antiviral and antibiotic drug (ab)use.

Finally, the most disturbing issue that this trial raises is the question of why it took nearly four years after the trial was stopped to publish the results. Dr. Atwood has speculated why this might be the case, namely to cover up the results that were unfavorable to Gonzalez. There is now no doubt that this trial was completely unethical right from the very beginning, but that lack of ethics was compounded by not having the results reported right away. In this, after having had a few days to think about it, I am going to have to strongly disagree with Dr. Atwood when he asserted, "A compelling argument can even be made that the JCO should not have published the report--as paradoxical as that sounds."
…

I can understand where he's coming from. This study clearly violates the Helsinki Declaration, to which JCO requires the clinical trials that it publishes to adhere. However, I find an it equally, if not more, compelling to take the view that the patients who suffered in the Gonzalez group will have suffered in vain if the results of this trial were not published. I also tend to take the view that shining a light on such a trial, in the form of publication, is a good thing in this particular case because it eliminates the uncertainty over whether the results were as bad as we know them to be. Let's put it this way: If the results were not published in a peer-reviewed journal but rather announced or mentioned in a report, they would seem less credible to shruggies. It is these people who need these bad results rubbed in their noses, the better to let the stench waft into their nasal passages and make them retch. When they ask, "What's the harm," we can tell them in no uncertain terms what the harm is. The same would apply if they were simply announced on ClinicalTrials.gov or mentioned in a report. It's just not the same as a peer-reviewed publication in one of the highest impact oncology journals there is. This is truly a case where the greater good can be served by disseminating this data far and wide as soon as possible by the most scientifically credible means necessary.

Supplements are untested Pharmaceuticals

Supplements like herbs are used by some instead (or in addition) of pharmaceuticals, but these supplements are in fact untested pharmaceuticals. In order to know that a pharmaceutical is safe, a proper clinical trial is needed with enough people in the treatment groups, enough people in the control group, proper blinding of the study and the recording of all adverse effects and the efficacy. If a supplement is not tested, it can either be a useless waste of money or it can be dangerous to your health. 

Since mandatory reporting requirements went into effect, the agency has seen a threefold increase in the number of all adverse events reported compared with the previous year. For example, from January through October 2008, FDA received 948 adverse event reports, compared with 298 received over the same time period in 2007. Of the 948 adverse event reports, 596 were mandatory reports of serious adverse events submitted by industry; the remaining 352 were voluntary reports, which include all moderate and mild adverse events reported and any serious adverse events reported by health care practitioners and consumers directly to FDA. However, FDA recently estimated that the actual number of total adverse events--including mild, moderate, and serious--related to dietary supplements per year is over 50,000, which suggests that underreporting of adverse events limits the amount of information FDA receives. To facilitate adverse event reporting for all FDA-regulated products, FDA is currently developing MedWatchPlus, an interactive Web-based portal intended to simplify the reporting process and reduce the time and cost associated with reviewing paper reports.

Moreover, nearly 32% of supplement-related AERs resulted in hospitalization between 2003-2008; 13% were life-threatening; and 4% resulted in death. Possible reasons for the underreporting are described thusly:

Experts have cited several possible reasons for underreporting related to dietary supplements, including reduced attribution of adverse effects to supplements due to the assumption that all dietary supplements are safe, the reluctance of consumers to report dietary supplement use to physicians, the failure to recognize chronic or cumulative toxic effects from their use, and a cumbersome reporting process

In other words, people assume supplements are safe, and therefore do not routinely associate adverse events that they might have with the supplements. The report also cites a number of problems that hamper the FDA, including limited information about supplements and their manufacturers (or even how many manufacturers there were ; the identity of ingredients in the various supplements; and the mild and moderate AERs made to companies. But the worst problem hampering the the FDA's ability to protect the public from dubious supplements is that it lacks mandatory recall authority. That's right. The FDA can recall drugs if it decides there is evidence that they are unsafe, but for supplements it has to prove they're unsafe before recalling them--yet another double standard favoring CAM.