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MISkeptics Does a Study On That

But it’s a study, so it must be true!

What makes a scientific study well, scientific?

We’ve all seen claims made by deniers, new age gurus, and pseudoskeptics where they make a claim, usually shared from some Facebook page talking about a dubious claim which is strangely backed up my a study. Where do these studies come from? How are they actually making it into the scientific community? And seriously, oil pulling?

This month we are going to take a look at the not-so-scientific journal world. How it came about, why it is so big and what people are doing about it.

Conversely, we will also look at what makes a real scientific study valid and how to spot the difference.

It’s not like anyone will stop sharing Natural News articles but at least it will help.

Come and join us for lively discussion, drinks, dinner and debate! This is a good event for Skeptics of Michigan to come together and discuss local, national, worldwide items affecting skeptics. All are welcome to listen and participate.

To RSVP for the talk, head to our Meetup Page, or our Facebook Page.

I look forward to seeing you there!

Homeopathic Quackery and Pharmacists

A few years ago when I began following skeptic blogs and podcasts, I learned about the existence of homeopathic remedies. Of note, two of the main doctrines of homeopathy include the law of similars and the law of infinitesimals. The law of similars is also known as ‘like cures like.’ Briefly, an individual’s symptoms may be relieved by administering homeopathic drugs which are known to cause in higher doses those same symptoms in healthy people. For example, homeopathic preparation of ipecac is indicated to relieve vomiting. Historically, healthy individuals would be given gradually increasing doses (non-homeopathic) of a substance to illicit any symptoms. Known as ‘provings,’ the symptoms were carefully documented and form the basis of the law of similars. (Sucks to be the guys who ‘proved’ mercury and lead.) The law of infinitesimal (also known as the doctrine of minimum dose) requires that homeopathic remedies be highly diluted prior to administration. Starting with the original powder or liquid, a homeopathic practitioner may dilute one part with 99 parts of solvent (either ethanol or water) to give a 1C (centidecimal) dilution. A 1 to 9 dilution is a 1X (decimal) dilution. Higher dilutions are achieved by taking one part of the prepared dilution and again diluting it with solvent. Therefore a homeopathic remedy labeled as 3X means that it underwent three 10-fold dilutions (equivalent to one part per 10^3). A 200C or 200CK indicates that it underwent 200 successive 100-fold dilutions (equivalent to one part per 10^400). Part of the dilution process involves vigorous shaking or banging of the bottle on a surface meant to transfer energy to the solution, a process called succussion. Interestingly, homeopathic remedies are suppose to become more potent the higher the dilution.

WARNING: Scientific jargon abound, but bear with me, as it will be over shortly.
Say you start with one liter of a 1 molar solution of sugar (6.022*10^23 molecules in a mole; molar means how many moles per liter). After a 1C dilution, you’d have a 0.01 molar solution (6.022*10^21 molecules per liter). At a 11C dilution, you’d have a 1*10^-22 molar solution (60 molecules per liter). At a 12C dilution, you’d have a 10^-24 molar solution (0.6 molecules per liter). [sound of tires screeching] Hang on; you can’t have a 0.6 molecule! There’s nothing left to dilute! There’s only solvent being diluted with even more solvent (ever try 190 proof alcohol?). Yet, homeopathic remedies are frequently found as 12C, 30C and even 200C preparations. These incredibly dilute solutions are often added dropwise to sugar pills for subsequent sale and administration to patients.

As a scientist, I deal with extremely dilute solutions every day. For example, a bacterium has a single molecule of DNA per cell. The volume of a bacterium like Escherichia coli is approximately 1×10^-15 liters (1 femtoliter) so a single DNA molecule is at a nanomolar concentration ( [1 molecule / 6.022*10^23 molecules per mole] / 1*10^-15 liters = 1.66*10^-9 molar or 1.66 nanomolar). Clearly, 1 molecule in a cell can be very important biologically but if you go below 1 molecule, there’s nothing. For the sake of argument, let’s say a single molecule makes it all the way through to the final dilution of a 30C preparation. A 100 mL volume has approximately 1000 drops. If one drop was added to each sugar pill, there would be only a 1 in 1000 chance that any of the sugar pills would have a single molecule of the original active ingredient. Further divide the pills for sale into bottles containing 50 pills; you now have only 1 in 20 bottles for sale having a single molecule of active ingredient. Sugar pills sprinkled with water or ethanol for sale must have an awesome profit margin (CVS figured this out, see picture below). Homeopaths  admittedly recognize the scientific conundrum and sidestep the issue entirely by proposing all sorts of nifty mechanisms involving water memory, nanoparticles, clathrates, or even silicates dissolved from the bottles used in the succussion process. Imagine silicate able to cure just about anything. You know what else has silicate (aka silicon dioxide)? Taco Bell’s seasoned ground beef. Mmmmm, homeopathic chalupas. j/k

Can you spot the CVS generic brand of Oscillococcinum? -Photo take 2/5/2011

In the 20th century, homeopathic  medicine waned in popularity steadily until the advent of the holistic health movement of the 1970’s and the “New Age” Movement of the 1980’s. Today, homeopathic remedies are being sold in the U.S. under the guise of ‘dietary supplements.’ Concerning to me is the sale of over-the-counter (OTC) homeopathic remedies by pharmacists, especially those employed at major chains like Walgreens, CVS and Wal-Mart. Homeopathic remedies are often sold alongside with conventional medicines  (click on picture to enlarge). Without the knowledge of what homeopathy is, it’s likely that consumers assume homeopathic remedies sold at a pharmacy are no different than herbal or conventional medicines. Just three years ago, I thought the same way. Now I know better and you know who should know better too? Pharmacists.

It’s a fair assumption that pharmacists are highly educated professionals well versed in the scientific method and should appreciate the discoveries made from its application. Yet, for a pharmacist to stock, recommend and sell OTC products that have not been proven to be safe or effective through application of the scientific method is just mind bottling. “You know, when things are so crazy it gets your thoughts all trapped, like in a bottle?” (Blade of Glory, 2007) As professionals, pharmacists pride themselves as being honest, having integrity, and wanting to offer patients the best level of care. However, the sale of homeopathic remedies violates the inherent high ethics and morals of pharmacists because homeopathy is quackery, plain and simple.

Quackery (aka health fraud) is defined by the FDA as, “the deceptive promotion, advertisement, distribution or sale of articles, intended for human or animal use, which are represented as effective to diagnose, prevent, cure, treat or mitigate disease, or provide a beneficial effect on health, but which have not been scientifically proven safe and effective for such purposes.” Homeopathic remedies have very low regulatory standards besides labeling of packages with the mandatory disclaimer, “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.” So in practice, a homeopathic product cannot be marketed with a specific claim, rather they are allowed non-specific/structural claims like, ‘boosts the immune system’ or ”shortens duration of flu-like symptoms.’ Of further concern is that dietary supplements like homeopathic remedies are explicitly exempt from being required to provide the FDA with documentation of their product’s safety and efficacy. It’s entirely up to the manufacturer to ensure their products are safe while at the same time they can manufacture as many sugar pills as they want and charge a premium for them. The FDA can do nothing unless consumers start complaining. Imagine if ‘Big Pharma’ was allowed to play by those rules. But I digress. Homeopathy clearly fits within the definition of health fraud, but still pharmacists are more than happy to sell these products.

11 Reasons Why Pharmacists Should Not Sell Homeopathic Remedies

  1. After 200 years, no conclusive scientific evidence exists for the effectiveness of homeopathic treatments (reviewed here, here, here, here, and here). A product that has been diluted so much that not a single molecule of the original active ingredient is present would require a highly implausible mechanism and break the laws of physics and chemistry as we know them.
  2. Homeopathic remedies are legally exempt from providing documentation to the FDA showing their products are safe. It’s solely up to the manufacturer to ensure safety. What could go wrong? Oh, right…You could lose your sense of smell, permanently. Or poison children.
  3. When pharmacists misuse their professional reputation to recommend products that are not known to be effective, patients may feel that they can forgo legitimate therapy.
  4. For added confusion, homeopathic ingredients are listed in Latin. For example, a popular product sold as a remedy of flu-like symptoms is Oscillococcinum. The ingredients are lists as Anas Barbariae Hepatis et Cordis Extractum – 200 CK. Think about it. Pharmacists are selling products that they themselves have no clue as to what’s in the box. By the way, the Latin translation is roughly, ‘extract of heart and liver from a duck.’ Yum!
  5. The American Pharmacists Association (APhA) endorses homeopathic products through several means. Firstly, the APhA accepts money from homeopathic manufacturers for booth rentals at APhA conventions and advertisements in their journals. Secondly, the APhA publish book chapters and articles written by homeopaths, guaranteeing a favorable bias of the material taught. Therefore, the professionalism of the APhA has been compromised. Pharmacists must refuse to sell homeopathic products because doing so legitimizes the non-professional stance taken by the APhA and other organizations, and further degrades the status of  the pharmacy.
  6. Selling homeopathic products dishonors the professional relationship with the patient and yields a dishonest profit. This practice reduces pharmacists to the level of hucksters and predators who prey on their unsuspecting patients.
  7. Selling homeopathic products is, at best, legally questionable. Any product stocked by a pharmacy is subject to an ‘implied warranty’. This is to ensure that products sold are fit for a particular purpose. Recently, pharmacists in the UK were the subject of four year investigation for selling homeopathic anti-malaria remedies to travelers headed to Africa. The cases were unfortunately dropped but let that be a warning to pharmacists who think that they are doing nothing wrong.
  8. Selling homeopathic products violates the ‘oath of a pharmacist,’ in which US graduates vow to ‘. . . apply my knowledge, experience, and skills to the best of my ability to assure optimal outcomes for my patients.’ Selling unproved products clearly and unequivocally violates this vow as optimal outcomes cannot be achieved with expensive placebos.
  9. Pseudo-medical practitioners wish to displace legitimate medicine. By only selling products proved safe and effective, pharmacists hold the line against the encroachment of quackery on conventional medicine. Conversely, selling homeopathic products hastens the erosion of conventional medicine and lowers that pharmacist to quackery. Those pharmacists are essentially no better than some scientifically illiterate health food store clerks. Selling homeopathic products thus lowers esteem for the pharmacist, the pharmacy and the profession at large.
  10. Homeopathic products appeal to the greed and profit motive. Health food stores are making huge profits off the sale these worthless products and pharmacies want a slice of the pie. “If the guy down the street is making money, why can’t I?” The argument that profit justifies the sale of homeopathic medicines is the identical justification used by illicit drug dealers, pimps, and illegal arms dealers. Profitable quackery is still quackery.
  11. Selling homeopathic products betrays a lack of intellectual honesty and rigor in thinking. To know the scientific method, but to ignore its power and utility is perhaps even worse than to be scientifically illiterate. Selling quack products lowers respect for the pharmacy in the eyes of physicians and others who adhere to the principles of legitimate medicine.

Survey of pharmacists regarding OTC homeopathic remedies

As part of my own ongoing investigation on homeopathic remedies, I conducted a survey of pharmacists located within Ann Arbor and Ypsilanti.  The survey was conducted February, 2011. A total of 7 pharmacists were surveyed from as many pharmacies, including Walgreens, CVS, Rite-Aid, Kroger, and K-Mart.

  • When did you receive your Pharm.D. degree?
    • Pharm.D.: Est. 2014, 2010, 2007, 2005, 2001; B.S.: 2006, 2001
  • Where did you receive your degree?
    • China (1), India (1), Nevada (1) , University of Michigan (4)
  • What is your definition of ‘evidence-based medicine’?
    • Provided some definition referring to evidence gained from clinical studies (5), Had never heard of ‘evidence-based medicine’ (2)
  • Rank the following in order of importance when selling an over-the-counter product: Safety, Evidence of efficacy, Patient preference
    • Safety::                                #1 (6), #2 (1), #3 (0)
    • Evidence of Efficacy*:: #1 (1), #2 (4), #3 (1)
    • Patient preference*::    #1 (0), #2 (1), #3 (5)
      *One pharmacist said many other factors should be considered
  • What is your definition of a homeopathic remedy?
    • “diluted ingredients” (2),”not chemicals” (1), “herbal/natural remedies” (3), “non-traditional” (1), and “medicine that works with the body” (1)
  • Have you ever sold a homeopathic remedy?
    • Yes (7), No (0)
  • Have you used a homeopathic remedy?
    • Yes (3), No (4)
  • In your opinion, should homeopathic remedies be sold by pharmacists?
    • Yes (5), No (1), Depends of the evidence (1)
  • Does the FDA mandate that homeopathic remedies be tested for safety and efficacy?
    • Yes (1), No (5), I don’t know (1)

If the store sold either Oscillococcinum or Zicam lozenges, two popular homeopathic remedies, the following questions were asked with the boxes in hand:

  • Can you tell me the ingredients of Oscillococcinum (Anas Barbariae Hepatis et Cordis Extractum – 200 CK)?
    • I don’t know (4), Diluted liver (1)
  • On a box of Oscilloccinum, what does 200CK mean?
    • Correct answer (0), I don’t know (4), Dosage (1)
  • On a box of Zicam, what does 2X mean?
    • Correct answer (0), I don’t know (5), 2 times dosage (1), 2 parts per million (1)

Results and Conclusions

The survey was hampered by the severe weather this past week. As more pharmacists are surveyed, this blog post will be updated. A few conclusions can be drawn from my limited survey. When selling an OTC product, safety is by far the #1 concern, regardless of the evidence of efficacy. This assertion is supported by a 2007 survey of pharmacists in Ireland. Pharmacists overwhelmingly approve of the sale of homeopathic remedies. Yet, none of the pharmacists could  fully translate the Latin ingredients or assess the dosage labeled on the homeopathic products presented to them. The majority were aware that the FDA does not regulate the safety of efficacy of these products. Most pharmacists surveyed were trained locally at the University of Michigan, College of Pharmacy.  Interestingly, the only pharmacist, educated outside of the US and had never heard of ‘evidence-based medicine’, asserted that homeopathic remedies were “not chemicals” and should not be sold by pharmacists. Based on a discussion with a Pharm.D. candidate, only recently has the U. of M. curriculum begun teaching about alternative medicines including homeopathy; all the others were never educated in school about homeopathic remedies. The quality of the Pharm.D. curriculum at U. of  M. will likely be a follow-up blog post.

Conflicts of Interest: The author is a skeptic and smolders when presented with stupidity, ignorance and greed. He has not been paid or plied with alcohol to write this post.
Acknowledgments: Professor Pray has been a big help in providing inspiration and references for this post.

Est. 2014, 2010, 2007, 2005, 2001; B.S.: 2001, 2006;
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