Lawsuit Science: Class action says homeopathic medicine doesn’t work


http://www.thejayfk.com/?p=960

On 31 August 2010, Gina Delarosa filed aclass action lawsuit  against Boiron, Inc. stating the company is “..defrauding Californians by claiming that a tablet called “Children’s Coldcalm” pellets will provide relief from: sneezing, runny nose, nasal congestion, sinus pain, headaches, and sore throat.”

What’s “Children’s Coldcalm® “?  It’s ahomeopathic medicine that Boiron sells .  That’s right!  A manufacturer of a homeopathic medicine is being sued because said homeopathic medicine doesn’t work.

Boiron wanted to nip this lawsuit in the bud .  On 27 July 2011, the courts said “nope ” to Boiron’s attempt to nip.  We’ve got a full-blown and undiluted homeopathic class action lawsuit  on our hands!

Ahead of the trial, let’s investigate the homeopathic medicine in question.  As we sort outColdcalm ® , keep in mind…

The principle of similars (or “like cures like”) is a central homeopathic principle. The principle states that a disease can be cured by a substance that produces similar symptoms in healthy people. [excerpt from here ] 

Unlike a drug like Tylenol® Cold Multi-Symptom Severe , the amount of an active ingredient  in homeopathic medicines usually isn’t given in milligrams (mg).  This is because homeopathic concoctions are often very dilute , so the active ingredient will be at some low concentration .  Dilution is another key point of homeopathy often referred to as the “law of minimum dose”.  In homeopathy, “…the lower the dose of the medication, the greater its effectiveness .”

Instead of mg for a homeopathic active ingredient amount, you’ll often see “X” or “C” next to an active ingredient.  As Dr. Stephen Barrett explains in Homeopathy: The Ultimate Fake …

Dilutions of 1 to 10 are designated by the Roman numeral X (1X = 1/10, 3X = 1/1,000, 6X = 1/1,000,000). Similarly, dilutions of 1 to 100 are designated by the Roman numeral C (1C = 1/100, 3C = 1/1,000,000, and so on).

Here’s a handy figure from the article Like Cures Like: Homeopathy …

 

Now that we’ve got the basics of homeopathy (“like cures like” and “law of minimum dose”) down, it’s time to get to the bottom of what’s in Coldcalm ® .

 

 

This homeopathic medicine has a lot of stuff in it.   Coldcalm ®   lists more active ingredients than Vick’s Children’s Nyquil ® .  What is all that stuff in Coldcalm ® ?  Let’s take a look…

Allium cepa: Plain ol’ onion . Seriously .  In the homeopathy vein of ”like cures like “, onion is the homeopathic go-to  for runny nose  and irritated, watery eyes .  Onion is present in a Coldcalm ®   dose at a concentration of “3C” or 1 part onion to 1,000,000 parts something else.  For a liquid homepathic medicine, this “something else” is usually  water, alcohol or some inactive ingredient .  For the Coldcalm ®  pellets, the “something else” is likely sucrose and lactose , two sugars listed as this product’s inactive ingredients.

Apis mellifica: If this sounds a lot like Apis mellifera  (the honey bee ) that’s because it ishoney bees.  This British Journal of Clinical Pharmacology  paper  details the production of apis mellifica…

For preparation of Apis mellifica, entire honey bees were first crushed in a grinder and 65% ethanol was then added (1:20, w/v).

Going with “like cures like “, one would assume Apis mellifica is for insect bites and stings , or perhaps a skin condition ….yes and yes.  But it’s also listed as a homeopathic treatment for sore throat .  Of course, “like cures like” is fairly open when it comes to Apis mellifica in homeopathy …

…Apis mellifica (honey bee) which causes pinkish red swelling with an itching and burning sensation in  healthy people.

Somehow, in  Coldcalm ® , this includes nasal congestion.  Apis mellifica is present in a Coldcalm ®   dose at a concentration of “6C” or 1 part Apis mellifica to 1,000,000,000,000 parts sugar.

Belladonna: This plant is in the same family  as  potatoes, tomatoes and chili peppers.  It’s Italian “beautiful lady” moniker  is due to a one-time beauty practice.  In the 16th and 17th century, ladies used  belladonna berry juice  eye drops to delate their pupils – the “in” look back then.  Belladonna is also known by another moniker – Deadly Nightshade . This plant contains a number of  poisonous  alkaloids  which, depending on the amount ingested, can cause  drying of skin and mucous membranes, dilated pupils, fever, elevated heart beat, restlessness, coma, respiratory failure, and convulsions. In the “like cures like” world of homeopathy, tiny doses of Belladonna would be used  to combat all those symptoms.  Belladonna is present in a Coldcalm ®   dose at a concentration of 6C or 1 part Belladonna to 1,000,000,000,000 parts sugar.  (Note the * next to Belladonna onColdcalm ® )

Eupatorium perfoliatum: Also known  as Common Boneset, this plant is a perennial wildflower.  Boneset has a history  of being a popular remedy  for flu symptoms and many other ailments .  This plant seems to be more traditional remedy then “like cures like” additive, i.e. most of its homeopathic uses aren’t for symptoms it induces at high levels.  Inlarge doses, Boneset  works as an emetic  (induces vomiting) and an aperient  (laxative).  In addition, Boneset is listed  as being hepatotoxic (liver damaging) and renal toxic (kidney damaging). As with most things, it’s all about dosage .   Boneset is present in Coldcalm ®   at a low dose of 3C or 1 part Boneset to 1,000,000 parts sugar.

Gelsemium sempervirens: Known in the U.S. as Carolina Jessamine , this plant is a flowering climbing vine .  This plant contains a number of alkaloids , two of which are motor nerve depressants.  Those two are gelsemine and gelseminine , with gelseminine noted by some  to be the more powerful poison .  The symptoms  of Gelsemium sempervirens poisoning are ”…muscular weakness including jaw drooping, headache, visual disturbance, dizziness, decrease in respiratory rate, and muscular spasms in the extremeties…”.  From that array of symptoms it’s easy to see how in homeopathy this pretty , but poisonous , plant has been used to treat a number of ailments .  In Coldcalm ® , Gelsemium sempervirens is supposedly treating a headache at dose of 6C.  That’s 1 part plant to 1,000,000,000,000 parts sugar – far, far, far below  a poisonous dose.

Kali bichromicum:  Though this sounds somewhat exotic, kali bichromicum ispotassium dichromate  [K2Cr2O7].  According to  PubChem , potassium dichromate “…has been used externally as an astringent, antiseptic, and caustic. When taken internally, it is a corrosive poison.” Potassium dichromate is all kinds of bad  at the right (wrong?) levels.  At acute toxicity levels …

…potassium dichromate is corrosive to the eyes, skin, and respiratory and gastro-intestinal tracts. In the eyes, pain, severe burns, conjunctivitis. On the skin, dermatitis, ulcerated sores, including perforation of the nasal septum. If inhaled, sorethroat, labored breathing, shortness of breath.

For the homeopathic medicine Coldcalm ® , all that bad seems to mean 6C of potassium dichromate is just the thing for “nasal discharge”.  The amount of 1 part potassium dichromate to 1,000,000,000,000 parts sugar is faaaaaaaaaaaar below  acute toxicity levels.

Nux vomica: With a name so similar to “vomit”, Nux vomica just doesn’t sound like a homeopathic active ingredient.  In homeopathy, Nux vomica is the dried seeds  of tree Strychnos nuxvomica L.  (Loganiaceae).  Yes, the strychnine tree.  Yes, as in thefamous poison  strychnine .  Nux vomica is full of active alkaloids , such as strychnine, brucine, and vomicine.  Of these alkaloids, strychnine packs the biggest punch .  Low or moderate doses of strychnine depart a host of unpleasant symptoms .  At high doses, strychnine can lead to an decidedly unpleasant  death .

Given all this unpleasantness, caution is employed  when using nux voxima for medicinal purposes.  As detailed in this J. Ethnopharmacol.  paper , the concentration of major alkaloids (like strychnine) Strychno nux-vomica seeds can be greatly decreased via a detoxification process.  Like other ingredients in Coldcalm ® , Nux vomica has been used for a long list of ailments .   Nervous disorders and paralysis , migraines ,insomnia , nausea , flu , nasal discharge … just to name a few.   It’s nasal discharge that the 3C 0f Nux vomica (1 part to 1,000,000 parts sugar)  in Coldcalm ®  is supposed to target.

Phytolacca decandra:  This plant is popularly known as American pokeweed  and it toocontains  poisonous compounds .  Pokeweed poisoning  is marked a list of horrible symptoms including vomiting, convulsions and difficulty breathing.  This Iowa State University  brief  on pokeweed states, “Because of the danger of human poisoning, pokeweed should be eradicated when discovered.”  But why boot a poisonous plant when you can dilute the hell out of it and use it in some homeopathic potion?  Especially a plant that has a history  of use in folk medicine.  In homeopathy, pokeweed is used  to alleviate a variety of discomforts including including vision disorders, warts and sore throat.  It’s that last discomfort that the 1 part pokeweed to 1,000,000,000,000 parts sugar (6C) inColdcalm ®  is to soothe.

Pulsatilla:  Full name Pulsatilla vulgaris, this perennial plant is also known as Pasque flower  and “crocus “.   This member of the Ranunculaceae (Buttercup) family is the official state flower of South Dakota .  As with other plants in Coldcalm ®  , this nice looking flower  has a not-so-nice side .  ”Any part of the plant can cause inflammation and blistering of the skin and muccous membranes.  Ingestion can cause gastric irritation, vomiting and diarrhea.”  The whole Ranunculaceae family has a bad reputation.

The sap of any plant of the family Ranunculaceae has a burning taste and may cause reddening of skin followed by swelling and even blistering. If swallowed in large quantities, stomach irritation may follow and further develop into stomach colic and extreme gastro-enteritis and diarrhea mixed with blood. [excerpt from here ]

…and like other plants in Coldcalm ® , Pasque flower  has a history  as a medicinal plant and has been used as a treatment for an assortment  of ailments  (rheumatism, boils, burns, eye conditions, menstruation-related ailments, urinary tract infections, etc.).  Amoung the long list  of discomforts  this flower supposedly treats is the loss of taste and smell , which is why Boiron put it in Coldcalm ® .  Of course, there isn’t very much Pasque flower in Coldcalm ®  at 1 part to 1,000,000,000,000 parts sugar (6C).

 

What’s the verdict?  Even though Coldcalm ®  contains some nasty stuff, none of this stuff is at a level that would likely hurt you*.  One could argue -hell, I would argue – that none of this stuff will “cure” you at extremely dilute levels, like in Coldcalm ® .  I don’t think homeopathic medicines offer any more relief than a placebo (see this@bengoldacre  article ).  Delarosa  is making a similar argument, “Children’s Coldcalm is nothing more than a sugar tablet.”  We’ll have to wait and see what argument Boiron comes up with to defend Coldcalm ® .  It’s now up to the courts to sort through the arguments and determine if Boiron defrauded its consumers with Coldcalm ® .

_____________

@DrRubidium
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