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Evidence Based Alchemy
                or
 How to Sell Nonsense as Medicine

           Willem Betz
          Meise 25/1/2013
Quality in Medicine has many aspects
   but 2 make all others IRRELEVANT
1. Does it Work ?
Effectiveness (NNT):
What is the use of a product that is cheap,
available, has no side effects …...but does not work?

2. Can it Harm ?
Safety (NNH):
It works, is cheap, well tolerated..but kills 1 in 1000
How do we Know if it Works?
:
              EBM: Strenght of Evidence
                                  Testimonies
                              Test tube (in vitro)
                          Animal experiments
                       Case reports, Case series
            *******************************************
                           One good RCT
                    More independent good RCTs
             Systematic Review of RCTs
                        EBM (Evidence Based Medicine)
                        SBM Science Based Medicine


The RCT, the randomised clinical trial with control group
Stupid, Misleading and Bad
•   Compare nonsense with nonsense in RCT
•   Compare with bad/insufficient treatment
•   Cherry pick studies (50 % !)
•   Publication bias – author bias
•   Misleading or intermediary end-points
•   Fishing or data-dredging, many end-points
•   Invent or select results (Benveniste bad blood)
•   No or bad blinding
•   Disregard plausibility
•   Unsubstantiated conclusions
•   Change the conclusions
Testimonies are NOT ≡ Proof
The satisfied customers may be sincere, but
without RCT we can not recommend a treatment:
• We do not know how many tried
• We do not know how many failed
• We do not know how many improved without
treatment
Thus we do not know if the treatment was better or
worse than doing nothing.
EBM needs Figures, DATA:
% yes, % no, % in control group
calculate NNT, NNH
Alternative or Complementary Medicine
Selling or recommending unproven treatments
  is QUACKERY
The term Alternative is just a commercial slogan
  for selling unproven treatments.
 Paradigma-Shift (Kuhn) not without proof
Integrative or Complementary Medicine:
  if you mix apple pie with cow pie, the result is
  not a better pie.
HOMEOPATHY
Samuel Hahnemann 1755-1843
Discovered that Quinine causes the
symptoms of Malaria in a healthy
Person ???
Diluted and Shaken quinine takes
away those symptoms ???
He was a pioneer of scientific
inquiry!!
Homeopathic Proving
Healthy volunteers take a product and describe what
   they feel, during several weeks.
Their reports determine the IMAGE of that product.
All images are recorded in a book: MATERIA MEDICA
“Law” of Similia: If the complaints of the patient match
   a description in the MM then the name of that
   product is the Diagnosis and Treatment.
“Law” of Dynamisation: The more diluted and
   succussed, (shaken and knocked) the stronger the
   remedy.
IMAGE of Kina = Quinine

Shivering ?
Fever ?
Fear ?
red skin rash ?
feeling weak ?
Was he Allergic ?
Homeopathic Medication is not ≡ Herbal

•   Blatta Orientalis = cockroach
•   Pediculus Capitis = lice
•   Cimex Lectularis = bed bugs
•   Cantharis = Spanish Fly
•   Coccinella Septempunctata = lady Bug
•   Lac Felinum = cat’s milk
•   Lac Dolphinum
•   Excrementum Caninum = dog sh***
•   Natrum Muriaticum = plain salt
•   Plutonium
•   Earth Rays
•   Luna, Sol
•   Berlin Wall
•   ……
HOMEO-IMAGES = NONSENS
• Many products give hundreds of symptoms.
• Sulphur gives 1.900 symptoms according to
  Hahnemann
• They even do provings with plain water (high
  dilutions)
Don’t believe me! Just read the Materia Medica
  and Convince Yourself. It’s on the Internet for
  Free!
Materia Medica (Kent):
         the Pulsatilla (Anemone Pratensis) Patient:

•   .. a very good medicine for women, for blondes, especially for tearful blondes. ..The
    Pulsatilla patient is found in any household where there are plenty of young girls …
• She imagines the company of the opposite sex a dangerous thing to cultivate, ..
• They imagine that milk is not good to drink, …
• Aversion to marriage is a strong symptom. A man takes it into his head that it is an
    evil thing to have sexual intercourse with his wife and abstains from it…
• he misuses and misapplies the Scriptures to his own detriment; ..
• This goes no until he becomes insane on other subjects, and then the tendency is
    to sit day after day in a taciturn way. …
• .. feels worse in a warm room and, relieved by motion. ..
• He craves highly spiced sausage, yet averse to pork alone.
So it continues for 14 pages
Homeopathy: there is Nothing in it
Serial Dilutions D=1/10, CH=1/100
• normal homeo-dilutions are 30-60 CH
• Post-Avogadro after 12 CH or D23 or +/-12K
• 20 CH (40 zero’s) is one drop in the Atlantic
  Ocean, 21 CH in 100 Oceans....
• Korsakow: K ( 300- 1000K is usual) = bottle is
  rinsed 1000 times
• memory of water are transferred to lactose
  granulae ? (sprayed an dried)
Homeopathic Cheating with Evidence ?
• Flooding: they give long list of “positive” articles.
• Studies listed as positive were not positive!
• Positive studies exist, but they have not been confirmed, have been
  refuted or retracted. They ignore the retractions. e.g. Riley’s allergic
  rhinitis was not confirmed in a better study (BMJ 2002)
• High Quality studies with negative results are ignored or omitted
  (E. Ernst, R. Almeida)
• They Change the conclusions of the authors. (Swiss study)
• The Leipzig group had to give back their 10.000 € award (F. Schmidt,
  Prof. K. Nieber und Prof. W. Süß 2003 )
• The Ennis proof failed in the BBC Horizon test for 1.000.000 $
• No proof yet for the “memory of water” (Benveniste)
• Homeopathy transferred by e-mail (digital information)
• The Montagier article proves nothing about homeopathy
The Solution: The Remedy Maker!
An advanced homeopathic and isopathic remedy maker
       for both professional and personal use.

Copy homeopathic, isopathic,
and nosode remedies.
Make isopathic or nosode
remedies from source
materials.
Make remedies directly from
bioenergy imbalances and
anti-bioenergy zones.
Price: $355 US
Homeopathy in the EU
• 1965 medication Laws: “Any claim on the curing or relieving
  symptoms or disease has to be solidly substantiated”.
  (EU Directives: EU 65/65/EEC , 75/319/EEC , 89/341/EEC).
• Result: since 1965 thousands of unproven medications were
  retracted, but…
• In 1992 the EU parliament voted a STRANGE EXCEPTION
  EU Directive 92/73/EEC: homeopathic and antroposophic
  medical products can be registered as medication without
  having to prove therapeutic efficacy.

  Justifications for this “Simplified Registration”:
• “We make no specific therapeutic claims for one product”.
  “Individualised treatments”
  “Conventional statistics are not applicable to homeopathy”
  (sic)
EU: LIMITATIONS were stipulated
Since the homeopaths stated that they can not give proof that
   one product is effective for a specific disease:

• No commercial or brand names,
• Only the start product and the number of dilutions and
  shakings can be mentioned.
• No mention of any disease or symptoms.
• Must be extremely diluted (1/10.000).
• Only for oral or external use.
• On the label: “Homeopathic Product without approved
  therapeutic indications”
EU: Limitations Disappear
• Multi-ingredient products (complexes) were allowed.
  They bear suggestive names ! (cardio, osteo, pulmo)
• Illegal flyers/booklets are openly distributed.
• 1998: The discrimination of HP was lamented in the EP
  (Chanterie): “Why are indications not allowed for HP ?”
• 2004: the consumer fraud is legalized. Medical
  indications can be mentioned if based on “tradition” or
  “homeopathic bibliography”.
• All countries must start registering this fraud.
False andMisleading Indications:
•     crataegus for the heart
•     sabal serrulata for the prostate
•     against variola or varicella (smalpox),
•     against anthrax,
•     against dioxine
•     against malaria…
•     against meningitis (fake vaccines)
• etc….

• IS THIS FRAUD ? YES, but no authority reacted
Results
• Homeo- products (HP) are sold in pharmacies, as
  medicines, with medical indications without any
  proof.
• Nobody can discern those products from pure
  lactose, water or alcohol. (challenge 10.000 € or
  1.000.000 € ) *
• Nobody can discern between two different HP
  (idem) *
• Nobody can discern between a “real” and one
  made by a Remedy Maker.
* If more diluted than D23 or C12, as most are.
EU-Pharmacopea = Alchemy ?



Based on the existing G German and F French (and USA)
data, but …
G and F use vague alchemistic names: is it chloride, chlorite
or chlorate ? (Cl, ClO² or ClO³)
G and F use different part of the plant,
G and F collect in different seasons,
One uses fresh plants, others use dried
Nobody cares!
“Prescibers and clients said: not relevant”
“All traditions should be legalised”.
“The effect of HP is not measurable with current allopathic
methods”
EU: Legal Definition of Homeopathic
       medicinal product HMP

2004/27/EC :
“Any medicinal product prepared from substances
  called homeopathic stocks in accordance with a
  homeopathic manufacturing procedure described
  by the European Pharmacopoeia or, in the
  absence thereof, by the pharmacopoeas
  currently used officially in the Member States. “
Translated: it is a HHMP is the homeopaths say so.
Challenge: Nobody can tell if a finished product is
  HMP or not (1 million euro)
CRITICISM on Homeopathy
•   No convincing proof.
•   They do not know diseases
•    They do not know the real CAUSES and often
    deny them. (e.g. anti-vaccination)
•    They make no verifiable DIAGNOSIS
•    Without diagnosis, PROGNOSIS is not possible
•   If every patient is different, how can they
    gather experience for future patients?
•   In contradiction with the laws of nature
EU Consumers Protection

  Laws on the safety of food and other products, on consumers'
  rights and on the protection of people's health.
  National governments must apply those laws.
  DG must check that the rules are being applied properly in all
  EU countries.
  Directive 2005/29/EC: List of commercial practices which are
  IN ALL CIRCUMSTANCES CONSIDERED UNFAIR:
  Nr 17: Falsely claiming that a product is able to cure illnesses,
  dysfunction or malformations.
EU Rules for Food
and Supplements
Any claim about curing disease is forbidden, unless for Registered Medications:
“Any claim on the curing or relieving symptoms or disease has to be solidly
substantiated”
(EU Directives: EU 65/65/EEC , 75/319/EEC , 89/341/EEC).

Claims on promoting health or preventing disease by food or food supplements,
Can be allowed, but !!!…each claim must first be approved by the EFSA:
http://www.efsa.europa.eu

EU Directive Nr. 1924/2006 Art. 13(5) & 14(1):
Health claim means any claim that states, suggests or implies that a relationship
exists between a food category, a food or one of its components and health.
EU: Food and supplements
     Hundreds of claims rejected by EFSA, are forbidden.




http://ec.europa.eu/food/food/labellingnutrition/claims/community_register/rejected_health_claims_en.htm
The Supplements and Herbs Industries
         are very Unhappy
Food Supplements

•   Bjelakovic, G., et al.,
•   Mortality in Randomized Trials of Antioxidant Supplements
•   for Primary and Secondary Prevention
•   Systematic Review and Meta-analysis,
•   JAMA, 27 februari 2007, 297: 842-857.

• “supplements with bèta-carotene, vit A and vit E
  Increase the risk of death with respectively 7, 16 and 4%.
• vit C shows no effect
Belgium: Registration of Quacks
   (Non-conventional Practices)
Law Colla 1999
Verdict: 5000 € per month for osteopaths !
Acupuncture
Homeopathy
Chiropractice
Osteopathy
Harmless ?
• Forgo a treatment that might help
• No information available on possible harm
• Antioxidants and herbs (vit. C en E) can neutralise the effect of
  needed therapies
• Dangerous Herbs.
• Antivaccination propaganda
• Anti-malaria homeopathy kills
• Fluor scare,
• Amalgam scare
• Financial hangover

• A Doctor who peddles CAM is……
• a quack with a license to kill"
The QUACK DETECTOR
•   Testimonies as Proof
•   Miraculous cures
•   No danger, no side effects
•   It’s a breakthrough!
•   Secret (ancient) formula discovered
•   One cure for many ailments
•   Buy my book!
•   Persecuted by science
•   They call normal medicine ALLOPATHY
•   Quantumfysics, vibrations, cosmic energy
•   De-toxify
•   Attacks on normal medicine
•   A conspiracy against them
CONCLUSION
• We do not want to forbid water or Lourdes
• Freedom of choice is only real if honest
  information is available and false claims
  forbidden.
• Complain against dishonest claims
• Once more: Witnesses and satisfied
  customers are NOT proof of efficacy
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Evidence based alchemy

  • 1. Evidence Based Alchemy or How to Sell Nonsense as Medicine Willem Betz Meise 25/1/2013
  • 2. Quality in Medicine has many aspects but 2 make all others IRRELEVANT 1. Does it Work ? Effectiveness (NNT): What is the use of a product that is cheap, available, has no side effects …...but does not work? 2. Can it Harm ? Safety (NNH): It works, is cheap, well tolerated..but kills 1 in 1000
  • 3. How do we Know if it Works? : EBM: Strenght of Evidence Testimonies Test tube (in vitro) Animal experiments Case reports, Case series ******************************************* One good RCT More independent good RCTs Systematic Review of RCTs EBM (Evidence Based Medicine) SBM Science Based Medicine The RCT, the randomised clinical trial with control group
  • 4. Stupid, Misleading and Bad • Compare nonsense with nonsense in RCT • Compare with bad/insufficient treatment • Cherry pick studies (50 % !) • Publication bias – author bias • Misleading or intermediary end-points • Fishing or data-dredging, many end-points • Invent or select results (Benveniste bad blood) • No or bad blinding • Disregard plausibility • Unsubstantiated conclusions • Change the conclusions
  • 5. Testimonies are NOT ≡ Proof The satisfied customers may be sincere, but without RCT we can not recommend a treatment: • We do not know how many tried • We do not know how many failed • We do not know how many improved without treatment Thus we do not know if the treatment was better or worse than doing nothing. EBM needs Figures, DATA: % yes, % no, % in control group calculate NNT, NNH
  • 6. Alternative or Complementary Medicine Selling or recommending unproven treatments is QUACKERY The term Alternative is just a commercial slogan for selling unproven treatments. Paradigma-Shift (Kuhn) not without proof Integrative or Complementary Medicine: if you mix apple pie with cow pie, the result is not a better pie.
  • 7. HOMEOPATHY Samuel Hahnemann 1755-1843 Discovered that Quinine causes the symptoms of Malaria in a healthy Person ??? Diluted and Shaken quinine takes away those symptoms ??? He was a pioneer of scientific inquiry!!
  • 8. Homeopathic Proving Healthy volunteers take a product and describe what they feel, during several weeks. Their reports determine the IMAGE of that product. All images are recorded in a book: MATERIA MEDICA “Law” of Similia: If the complaints of the patient match a description in the MM then the name of that product is the Diagnosis and Treatment. “Law” of Dynamisation: The more diluted and succussed, (shaken and knocked) the stronger the remedy.
  • 9. IMAGE of Kina = Quinine Shivering ? Fever ? Fear ? red skin rash ? feeling weak ? Was he Allergic ?
  • 10. Homeopathic Medication is not ≡ Herbal • Blatta Orientalis = cockroach • Pediculus Capitis = lice • Cimex Lectularis = bed bugs • Cantharis = Spanish Fly • Coccinella Septempunctata = lady Bug • Lac Felinum = cat’s milk • Lac Dolphinum • Excrementum Caninum = dog sh*** • Natrum Muriaticum = plain salt • Plutonium • Earth Rays • Luna, Sol • Berlin Wall • ……
  • 11. HOMEO-IMAGES = NONSENS • Many products give hundreds of symptoms. • Sulphur gives 1.900 symptoms according to Hahnemann • They even do provings with plain water (high dilutions) Don’t believe me! Just read the Materia Medica and Convince Yourself. It’s on the Internet for Free!
  • 12. Materia Medica (Kent): the Pulsatilla (Anemone Pratensis) Patient: • .. a very good medicine for women, for blondes, especially for tearful blondes. ..The Pulsatilla patient is found in any household where there are plenty of young girls … • She imagines the company of the opposite sex a dangerous thing to cultivate, .. • They imagine that milk is not good to drink, … • Aversion to marriage is a strong symptom. A man takes it into his head that it is an evil thing to have sexual intercourse with his wife and abstains from it… • he misuses and misapplies the Scriptures to his own detriment; .. • This goes no until he becomes insane on other subjects, and then the tendency is to sit day after day in a taciturn way. … • .. feels worse in a warm room and, relieved by motion. .. • He craves highly spiced sausage, yet averse to pork alone. So it continues for 14 pages
  • 13. Homeopathy: there is Nothing in it Serial Dilutions D=1/10, CH=1/100 • normal homeo-dilutions are 30-60 CH • Post-Avogadro after 12 CH or D23 or +/-12K • 20 CH (40 zero’s) is one drop in the Atlantic Ocean, 21 CH in 100 Oceans.... • Korsakow: K ( 300- 1000K is usual) = bottle is rinsed 1000 times • memory of water are transferred to lactose granulae ? (sprayed an dried)
  • 14. Homeopathic Cheating with Evidence ? • Flooding: they give long list of “positive” articles. • Studies listed as positive were not positive! • Positive studies exist, but they have not been confirmed, have been refuted or retracted. They ignore the retractions. e.g. Riley’s allergic rhinitis was not confirmed in a better study (BMJ 2002) • High Quality studies with negative results are ignored or omitted (E. Ernst, R. Almeida) • They Change the conclusions of the authors. (Swiss study) • The Leipzig group had to give back their 10.000 € award (F. Schmidt, Prof. K. Nieber und Prof. W. Süß 2003 ) • The Ennis proof failed in the BBC Horizon test for 1.000.000 $ • No proof yet for the “memory of water” (Benveniste) • Homeopathy transferred by e-mail (digital information) • The Montagier article proves nothing about homeopathy
  • 15. The Solution: The Remedy Maker! An advanced homeopathic and isopathic remedy maker for both professional and personal use. Copy homeopathic, isopathic, and nosode remedies. Make isopathic or nosode remedies from source materials. Make remedies directly from bioenergy imbalances and anti-bioenergy zones. Price: $355 US
  • 16. Homeopathy in the EU • 1965 medication Laws: “Any claim on the curing or relieving symptoms or disease has to be solidly substantiated”. (EU Directives: EU 65/65/EEC , 75/319/EEC , 89/341/EEC). • Result: since 1965 thousands of unproven medications were retracted, but… • In 1992 the EU parliament voted a STRANGE EXCEPTION EU Directive 92/73/EEC: homeopathic and antroposophic medical products can be registered as medication without having to prove therapeutic efficacy. Justifications for this “Simplified Registration”: • “We make no specific therapeutic claims for one product”. “Individualised treatments” “Conventional statistics are not applicable to homeopathy” (sic)
  • 17. EU: LIMITATIONS were stipulated Since the homeopaths stated that they can not give proof that one product is effective for a specific disease: • No commercial or brand names, • Only the start product and the number of dilutions and shakings can be mentioned. • No mention of any disease or symptoms. • Must be extremely diluted (1/10.000). • Only for oral or external use. • On the label: “Homeopathic Product without approved therapeutic indications”
  • 18. EU: Limitations Disappear • Multi-ingredient products (complexes) were allowed. They bear suggestive names ! (cardio, osteo, pulmo) • Illegal flyers/booklets are openly distributed. • 1998: The discrimination of HP was lamented in the EP (Chanterie): “Why are indications not allowed for HP ?” • 2004: the consumer fraud is legalized. Medical indications can be mentioned if based on “tradition” or “homeopathic bibliography”. • All countries must start registering this fraud.
  • 19. False andMisleading Indications: • crataegus for the heart • sabal serrulata for the prostate • against variola or varicella (smalpox), • against anthrax, • against dioxine • against malaria… • against meningitis (fake vaccines) • etc…. • IS THIS FRAUD ? YES, but no authority reacted
  • 20. Results • Homeo- products (HP) are sold in pharmacies, as medicines, with medical indications without any proof. • Nobody can discern those products from pure lactose, water or alcohol. (challenge 10.000 € or 1.000.000 € ) * • Nobody can discern between two different HP (idem) * • Nobody can discern between a “real” and one made by a Remedy Maker. * If more diluted than D23 or C12, as most are.
  • 21. EU-Pharmacopea = Alchemy ? Based on the existing G German and F French (and USA) data, but … G and F use vague alchemistic names: is it chloride, chlorite or chlorate ? (Cl, ClO² or ClO³) G and F use different part of the plant, G and F collect in different seasons, One uses fresh plants, others use dried Nobody cares! “Prescibers and clients said: not relevant” “All traditions should be legalised”. “The effect of HP is not measurable with current allopathic methods”
  • 22. EU: Legal Definition of Homeopathic medicinal product HMP 2004/27/EC : “Any medicinal product prepared from substances called homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeas currently used officially in the Member States. “ Translated: it is a HHMP is the homeopaths say so. Challenge: Nobody can tell if a finished product is HMP or not (1 million euro)
  • 23. CRITICISM on Homeopathy • No convincing proof. • They do not know diseases • They do not know the real CAUSES and often deny them. (e.g. anti-vaccination) • They make no verifiable DIAGNOSIS • Without diagnosis, PROGNOSIS is not possible • If every patient is different, how can they gather experience for future patients? • In contradiction with the laws of nature
  • 24. EU Consumers Protection Laws on the safety of food and other products, on consumers' rights and on the protection of people's health. National governments must apply those laws. DG must check that the rules are being applied properly in all EU countries. Directive 2005/29/EC: List of commercial practices which are IN ALL CIRCUMSTANCES CONSIDERED UNFAIR: Nr 17: Falsely claiming that a product is able to cure illnesses, dysfunction or malformations.
  • 25. EU Rules for Food and Supplements Any claim about curing disease is forbidden, unless for Registered Medications: “Any claim on the curing or relieving symptoms or disease has to be solidly substantiated” (EU Directives: EU 65/65/EEC , 75/319/EEC , 89/341/EEC). Claims on promoting health or preventing disease by food or food supplements, Can be allowed, but !!!…each claim must first be approved by the EFSA: http://www.efsa.europa.eu EU Directive Nr. 1924/2006 Art. 13(5) & 14(1): Health claim means any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its components and health.
  • 26. EU: Food and supplements Hundreds of claims rejected by EFSA, are forbidden. http://ec.europa.eu/food/food/labellingnutrition/claims/community_register/rejected_health_claims_en.htm
  • 27. The Supplements and Herbs Industries are very Unhappy
  • 28. Food Supplements • Bjelakovic, G., et al., • Mortality in Randomized Trials of Antioxidant Supplements • for Primary and Secondary Prevention • Systematic Review and Meta-analysis, • JAMA, 27 februari 2007, 297: 842-857. • “supplements with bèta-carotene, vit A and vit E Increase the risk of death with respectively 7, 16 and 4%. • vit C shows no effect
  • 29. Belgium: Registration of Quacks (Non-conventional Practices) Law Colla 1999 Verdict: 5000 € per month for osteopaths ! Acupuncture Homeopathy Chiropractice Osteopathy
  • 30. Harmless ? • Forgo a treatment that might help • No information available on possible harm • Antioxidants and herbs (vit. C en E) can neutralise the effect of needed therapies • Dangerous Herbs. • Antivaccination propaganda • Anti-malaria homeopathy kills • Fluor scare, • Amalgam scare • Financial hangover • A Doctor who peddles CAM is…… • a quack with a license to kill"
  • 31. The QUACK DETECTOR • Testimonies as Proof • Miraculous cures • No danger, no side effects • It’s a breakthrough! • Secret (ancient) formula discovered • One cure for many ailments • Buy my book! • Persecuted by science • They call normal medicine ALLOPATHY • Quantumfysics, vibrations, cosmic energy • De-toxify • Attacks on normal medicine • A conspiracy against them
  • 32. CONCLUSION • We do not want to forbid water or Lourdes • Freedom of choice is only real if honest information is available and false claims forbidden. • Complain against dishonest claims • Once more: Witnesses and satisfied customers are NOT proof of efficacy