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Critical Thinking in Medicine Eric S. Farbman, MD Scams Hoaxes Parkinson’s Disease: Bogus Treatments Eric S. Farbman, MD Quackery Hoaxes, Scams, Quackery Non-medical treatments without proven benefit Medical fraud Designed to enrich the promoter of the treatment more so than the patient

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Critical Thinking in Medicine

Eric S. Farbman, MD

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Parkinson’s Disease:Bogus Treatments

Eric S. Farbman, MD


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Hoaxes, Scams, Quackery

  • Non-medical treatments without proven benefit

  • Medical fraud

  • Designed to enrich the promoter of the treatment more so than the patient

  • In some cases, these can be dangerous to the health of the patient as well

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Why Are People Vulnerable?

  • Lack of suspicion—if it is on television, the internet, etc., then it must be true

  • Overconfidence—some people believe that they are better equipped than scientists in determining whether something works

  • Desperation—the sincere hope that something works when nothing else has

  • Conspiracy—distrustful of the medical profession but attracted to “natural” methods

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Why Do the Methods Seem to Work?

  • There is a poor grasp of innate probability

    • In a group of 23 people, what are the odds that two share the same birthday?

  • There is a belief that all effects must have deliberate causes

  • There is a tendency towards selective memory

  • There is the placebo effect

  • There is a desire to please the individual

  • There is the natural course of the disease

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What is Quackery?

  • It is the promotion of methods that have no evidence and lack a scientific rationale

  • Malpractice usually involves negligence rather than fraud

  • Some promoters are scam artists, some are blind “true believers”

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Types of Hoax Treatments

  • Vitamins/Supplements

  • Procedures

  • “Alternative medicine” practitioners

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Getting a Medication Approved

  • Since 1938, every medication has to go through a New Drug Application (NDA) process before getting approval in the U.S.

  • The goals of the NDA are:

    • Is the drug safe and effective for its proposed use, and do the benefits outweigh the risks?

    • Is the labelling (package insert) appropriate, and what should it contain?

    • Are the manufacturing methods adequate to maintain the drug’s identity, strength, and purity?

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Studies Required by the FDA

  • First the sponsor must submit data showing that the drug is reasonably safe for use in small-scale clinical studies

  • At this pre-clinical stage, the FDA will ask for:

    • A pharmacological profile of the drug

    • Determine acute toxicity in at least two species of animals

    • Conduct short-term toxicity studies ranging from two weeks to three months

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Studies Required by the FDA:On the Road to Drug Approval

  • Phase I: Develop drug’s safety profile

    • Normally subjects are healthy volunteers

    • Determines how drug is absorbed, distributed in the body, metabolized, and excreted

  • Phase II: Determine the drug’s safety and assess side effects

    • Given to volunteers who have the disease

    • Determine optimal dosage of the drug

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Studies Required by the FDA:On the Road to Drug Approval

  • Phase III: Verify the effectiveness of the drug against the condition that it targets

    • This also continues to investigate the safety of the drug and record possible side effects and adverse reactions from long-term use.

    • These studies are randomized, double-blind, placebo-controlled studies.

    • Often have at least 1000 patients enrolled

    • If the medication is effective, the trial is deemed successful—“pivotal”. Normally two pivotal trials are needed to ensure validity of the trials

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Studies Required by the FDA:After Drug Approval

  • Phase IV: Once the drug is on the market, the company must continue to perform observational studies to evaluate the drug’s safety during routine use.

    • The company may also monitor any usage of the drug for un-approved indications.

    • Trials may be done based on those usages, but the company CANNOT advertise “off-label” use

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Studies Required forSupplement Approval


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Health and Education Act of 1994

  • Defined a dietary supplement as:

    • A product (other than tobacco) that is intended to supplement the diet

    • Is intended for ingestion in pill, capsule, tablet, or liquid form

    • Is not represented for use as a conventional food

    • Is labelled as a “dietary supplement”

  • Nutritional support statements do not have to be approved by the FDA

  • This law has made it very difficult for the FDA to ban dangerous dietary supplements.

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“Legitimate” Supplements

  • Vitamin E

  • Gluathione

  • Coenzyme Q10

  • Vitamin B6

  • Folic Acid

Which of these agents has a double-blind trial that supports its benefit in PD?

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CoEnzyme Q10

  • Eighty people in study

  • Randomized to placebo, 300mg/day, 300mg twice/day, 300mg 4x/day

  • Followed for 16 months or until the patient needed treatment with levodopa

  • Primary variable was a change in UPDRS

  • Statistically signifcant benefits seen at highest dose, trending towards benefit at lower doses

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Why Is CoQ10 Thought to Work?

  • Causes of Parkinson’s Disease are not known

  • Thought to be at least partially due to oxidation (“rusting”) of the brain

  • CoQ10 is a potent anti-oxidant

  • So, what about other anti-oxidants?

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Vitamin E

  • One of the few supplements to have a well-designed negative trial

  • Original selegiline trials had four arms

    • Selegiline/Placebo

    • Selegiline/Vitamin E

    • Placebo/Vitamin E

    • Placebo/Placebo

  • No effect on progression of PD by itself

  • No enhancement of selegiline in combination

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  • 9 patients with early, untreated PD were given IV gluathione 600mg twice/day for 30 days

  • All improved significantly after therapy as measured by CURS

    • Evaluates rigidity, tremor, speech, facial expression, bradykinesia, gait, postural stability

  • After 30 days of therapy were completed, the therapeutic effect lasted an additional 2 months

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Ropinirole (n=464)



Placebo (n=464)





Percentage of Patients






















Problems with Gluathione Study

  • Very small sample size

  • No control group—no placebo arm

  • Original study done in 1996; where are the follow-up studies?

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Other Treatments

  • Prakotin

    • I’m not sure what it is

    • It shows up on some websites

    • The word “prakotin” does not show up in the medline database

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Low Dose Naltrexone

  • Naltrexone was approved by the FDA in 1984

  • Dose was 50mg for the purpose of helping heroin or opium addicts

    • Works by blocking opioid receptors

  • Supposedly a smaller dose (4.5mg) enhances the body’s immune system and its response to many diseases including Parkinson’s disease

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Low Dose Naltrexone (cont’d)

  • There is nothing in the literature to support its use in neurological disease

  • There is virtually nothing in the literature to support its use in anything

  • Any benefits reported for Parkinson disease are purely anecdotal

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  • A chelator is an organic compound that forms stable bonds with metal atoms.

  • They often are used for acute metal toxicity

  • Often times they have serious side effects

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Chelating Agents

  • Dimercaprol

    • Given intramuscularly

    • Used for arsenic, lead, mercury, cadmium poisoning

    • Side effects: Headache, nausea, vomiting

  • Penicillamine

    • Treatment for copper poisoning and Wilson’s disease

    • Side effects: Aplastic anemia, lupus, hemolytic anemia

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Chelating Agents (cont’d)

  • Edetate (EDTA)

    • Possible chelator of many things

    • Usually used for lead poisoning

    • Side effect: nephrotoxicity

  • Deferoxamine

    • Used for acute iron intoxication

    • Does not cross blood brain barrier

    • Side effects: skin reactions, neurotoxicity (i.e. retinal degeneration), hepatic and renal dysfunction, severe coagulopathies, hypotensive shock

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Chelation Therapy

  • There are no trials that show any benefit in PD

  • Even if we assume that excess iron is part of the pathology, there is no chelator that can effectively cross into the brain to remove this iron without side effects

  • There are well-designed trials for other conditions which have yielded negative results

  • Using chelation instead of proven treatments (i.e. CABG) can have fatal consequences

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Hyperbaric Medicine

  • The delivery of pressurized oxygen to the body

  • Useful (and approved) for treating

    • Decompression sickness (“The Bends”)

    • Carbon Monoxide Poisoning

    • Cyanide poisoning

    • Burns

    • Necrotizing soft tissue infections

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Hyperbaric Medicine in PD

  • 2 abstracts/articles from various International Congresses on Hyperbaric Medicine

  • One article (originally in Russian literature)

  • All supposedly show benefit

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Hyperbaric in PD: Abstract 1

  • 72 y.o. male diagnosed with idiopathic PD

  • Started on sinemet 10/100 three times/day

  • Eighteen months after diagnosis, he started on hyperbaric oxygenation and had great results. He was also able to come off of his sinemet

  • Problems:

    • Dose of sinemet is insufficient

    • Disease is probably mild at time of treatment

    • Scale used to rate improvement is not validated

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Hyperbaric in PD: Abstract 2

  • Fifteen patients (8 men, 7 women)

    • Etiology of PD:

      • 7 idiopathic

      • 4 vasculopathic

      • 3 post-encephalic

      • 1 other kind

    • No controls

    • Nothing said about medication changes

    • Difficult to know what to make of results

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Hyperbaric in PD: Russian article

  • 64 patients (29 men, 35 women)

  • Duration of illness ranged from 1 – 15 years

  • Etiology

    • Atherosclerosis of cerebral vessels in 49 patients

    • This combined with arterial hypertension in 6

    • History of encephalitis in 8

    • Closed head trauma in 1

  • Results:

    • “Good treatment results were noted in 18…”

    • “Therapeutic effect was considered satisfactory in 26…”

    • No measurement scales of any kind were used!

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  • One study on alternative medicine use in PD shows that 10% of patients will try acupuncture

  • An open-label trial of 25 patients with idiopathic PD were followed for 6 months

    • No significant improvement in treatment measures

    • 2.4 worsening on UPDRS motor scores

    • 16% improvement in quality of life scale

    • 29% improvement on depression scale

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Acupuncture (cont’d)

  • Because of this, a randomized, controlled double-blind study was done.

  • 14 patients were enrolled

  • There were no statistically significant changes in the outcomes measured

  • In the patients who received true acupuncture, there was a trend towards improvement in the quality of life scale

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Acupuncture (cont’d)

  • One study compared two groups, differing the number of treatments between them

  • There were no differences on the Parkinson motor scales, quality of life scales, or psychiatric symptoms measurements

  • A recent meta-analysis of all acupuncture in PD was published

    • “Evidence for acupuncture…is not convincing.”

    • Sample sizes are too small to draw conclusions

    • No evidence for acupuncture vs. placebo adjustments or acupuncture + drugs vs. drugs only

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“What are the principal functions of the spine?

To support the head

To support the ribs

To support the chiropractor.”

BJ Palmer, 1952,

Questions and Answers about Chiropractic

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Chiropractic Principles

  • Many chiropractors are against

    • childhood vaccinations

    • medications in general

  • There are chiropractors who claim that their adjustments can fix

    • ear infections

    • asthma

    • just about everything

  • Many chiropractor recommend supplements which they themselves sell

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Evidence-Based Analysis of Some Chiropractic Practices

  • Full spine X-rays

    • There is no evidence to support the use of this

    • This is a large radiation exposure

    • The films are usually of poor quality

  • Spinal manipulations

    • There is some evidence for benefit of lower spinal manipulations; it is transient and similar to PT

    • There is no evidence for any other adjustments

    • There is no evidence for any benefit in children

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What About Chiropractic with PD?

  • If you do a web search, there will be over 3000 hits

  • Many chiropractor websites talk about the scientific evidence of “upper cervical” adjustments in the treatment of PD

  • They are all referring to the same article

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Examining the Literature

  • What do PD and MS have in common?

    • Answer: They are both treated by neurologists.

    • Not much else that I can see

  • Diagnostic tests used in this trial included paraspinal digital infrared imaging and laser-aligned radiography

    • Neither technique is supported by any medical literature

    • In 2000 after reviewing more than 2500 articles, the AAN concluded that paraspinal imaging is “unacceptable as a clinical tool” for diagnosing low back pain or neuromuscular disease

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Other Problems

  • Patients were questioned for a history of head trauma (retrospective bias)

  • There were no PD scales used in the analysis of how the patients did. It was based on subjective reports of patients and changes on the erroneous tests mentioned before

  • Apparently all of the patients also had subluxations that were corrected

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What is a Subluxation?

  • The definition varies even between chiropractors

  • In general, they are thought to cause “nerve interference” and are the cause of the problems

  • Even though they are supposedly visible on x-rays, radiologists never mention them

The medical definition of a subluxation is where the bony surfaces of a joint no longer face each other exactly but remain partially aligned. This condition would not be amenable to chiropractic.

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So, Is the Chiropractor Doing Anything to Help in PD?

  • The study listed above did not have a control group to control for placebo effect

  • There is a study unrelated to chiropractic looking at the benefit of massage therapy

  • 7 patients received eight 1-hr sessions of whole body massage over eight weeks

  • Patients reported enjoying the massage and also reported benefits on quality of life surveys

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Which Alternative Medicine Treatments Should Be Used?

  • The terms conventional medicine and alternative medicine should not be used

  • We should look at treatments as proven, experimental, or questionable

  • From a 1998 JAMA editorial:

    “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…is irrelevant.”

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Borromeil A, et al. OTI (HBOT) efficiency in decompensated-complicated PD. In: Oriani G, Wattel F. Proceedings of the Twelfth International Congress on Hyperbaric Medicine, 1998.

Cristian A, Katz M, Cutrone E, Walker RH. Evaluation of acupuncture in the treatment of PD: A double-blind pilot study. Movement Disorders 20(9): 1185-1188, 2005.

Elster E. Eighty-one patients with MS and PD undergoing upper cervical chiropractic care to correct vertebral subluxation: A retrospective analysis. J Vertebral Subluxation Res 6:1-9, 2004.

Elster E. Upper cervical chiropractic management of a patient with PD: A case report. Journal of Manipulative and Physiological Therapeutics 23(8): 573-577, 2000.

Eng ML, Lyons KE, Greene MS, Pahwa R. Open-label trial regarding the use of acupuncture and Yin Tui Na in PD Outpatients: A pilot study on efficacy, tolerability, and quality of life. Journal of Alternative and Complementary Medicine 12(4): 395-399, 2006.

Fontanarosa PB, Lundberg GD. Alternative medicine meets science. JAMA 280:1618-1619, 1998.

Hoggard ML, Johnson KE, Shirachi DY. Hyperbaric oxygen treatment of a PD patient: A case study. In: Cramer FS. Proceedings of the Fourteenth International Congress on Hyperbaric Medicine, 2003: 206-209.

Lee MS, Shin B, Kong JC, Ernst E. Effectiveness of acupuncture for Parkinson disease: A systematic review. Movement Disorders 23(11): 1505-1515, 2008.

Kaur D, Andersen JK. Ironing out PD: is therapeutic treatment with iron chelators a real possibility? Aging Cell 1: 17-21, 2002.

Neretin VYa, Lobov MA, Kotov SV, Cheskidova GF, Molchanova GS. Hyperbaric oxygenation in comprehensive treatment of parkinsonism. Neuroscience & Behavioral Physiology 20(6): 490-492, 1990.

Parkinson Study Group. Effects of tocopherol and deprenyl on the progression of disability in early PD. New Engl J Med, 328: 176-183, 1993.

Paterson C, Allen JA, Browning M, Barlow G, Ewings P. A pilot study of therapeutic massage for people with PD: The added value of user involvement. Complementary Therapies in Clinical Practice 11: 161-171, 2005.

Rajendran PR, Thompson RE, Reich SG. The use of alternative therapies by patients with Parkinson’s disease. Neurology 57: 790-794, 2001.

Sechi G, et al. Reduced intravenous glutathione in the treatment of early PD. Prog Neuropsychopharmacol Biol Psychiatry 20: 1159-1170, 1996.

Shulman LM, et al. Acupuncture therapy for the symptoms of PD. Movement Disorders 17(4): 799-802, 2002.

Shults CW, et al. Effects of coenzyme Q10 in early PD: Evidence of slowing of the functional decline. Arch Neurol 59: 1541-1550, 2002.

Smith JP, et al. Low-dose naltrexone therapy improves active Crohn’s disease. American Journal of Gastroenterology 102: 820-828, 2007.

Weber C, Ernst ME. Antioxidants, supplements, and Parkinson’s disease. Annals of Pharmacotherapy 40: 935-938, 2006.