Its Truth Only Partially Known

It was while Samuel Hahnemann was translating a book by William Cullen in 1789 that he encountered a description of how Peruvian bark could be used in treating malaria.  In his book, Cullen attributed the effectiveness of the bark to its bitter and astringent properties.  Only 24 years old at the time, Hahnemann impetuously added a footnote to the translation disagreeing with the explanation and noting that there were other substances even more bitter and astringent that Peruvian bark that were were ineffective against malaria.  Instead, Hahnemann drew from his own experience taking toxic doses of the herb, conscious of how his body responded with fever and chills that he found similar to the symptoms of malaria. 

It was thus that Hahnemann developed the “law of similars” that is embraced by homeopaths, the word “homeopathy” being a combination of the Greek words “homoios” (“similar”) and “pathos” (“suffering”).  The idea was that disease could be prevented by using a substance to cause the body to react in a way that was similar to its reaction to disease.  While homeopathy is not accepted by modern medical science, the idea was not particularly outlandish considering the state of medical understanding at the time.  It was, after all, around the same time that Edward Jenner discovered that smallpox could be prevented by deliberating infecting people with small doses of cowpox to produce symptoms similar to those of smallpox.  I described some of the history of that development of vaccination here

Because the substances used to induce certain conditions were toxic and potentially dangerous, Hahnemann proposed to use extreme dilutions, so much so that none of the original substance would remain.  He proposed dilutions of 30C, meaning that the substances were to be diluted by a factor of 100, with the dilution repeated 30 times.  His proposed dilution is accordingly 10-60, a dilution so severe that it would be necessary to consume a liquid remedy that is roughly 10 billion times the volume of the Earth in order to consume a single molecule of the substance.  The dilution is so great that the effectiveness of homeopathic remedies is often attributed to the placebo effect. 

While homeopathic medicine had a considerable following through much of the 19th century, it was ultimately displaced by the development of modern medicine around the beginning of the 20th century.  Prompted primarily by concerns about the potential toxicity and side effects of now-conventional medicines, homeopathy began a resurgence sometime in the late 1970’s or early 1980’s.  There are virtually no adverse side effects with homeopathic treatments because the active ingredients have been so diluted as not even to be present, and this is one of its main attractions.

But some companies have wished to have their cake and to eat it to.  The cold remedy Zicam, taken as a nasal spray, is a notable case in point.  Marketed as a homeopathic remedy, it is prepared with highly diluted galphimia glauca, histamine dihydrochloride, luffa operculata, and sulfur.  It also includes only modestly diluted zinc acetate at a dilution of 2X, i.e. 1/100th dilution, and zinc gluconate at a dilution of 1X, i.e. 1/10th dilution.  These zinc compounds are at a level where they may still be biologically active, suggesting that the remedy is intentionally prepared so that it may be marketed as a safe homeopathic remedy while also including a biologically effective solution of 10% zinc gluconate. 

In 1999, a small number of physicians began noting that some of their patients developed anosmia — loss of the sense of smell — after consuming Zicam.  Familiar with studies dating from at least the 1930’s associating intranasal application of zinc sulfate with anosmia, those physicians questioned whether there was sufficient zinc compound in the remedy to be causing anosmia in patients.  There have been a number of reports suggesting an association, but the numbers are small — small enough that the manufacturer maintains they are not statistically significant while noting that there are many causes for anosmia.  It is fair to say that it remains unclear whether the zinc compounds in Zicam are responsible. 

Last week, the Supreme Court of the United States heard oral arguments in the case of Matrixx Initiatives v. Siracusano.  At issue is whether Matrixx, the manufacturer of Zicam, had a duty to report the concerns over a causal relationship between Zicam use and anosmia to investors.  Even if public response is based on an unsubstantiated link, there is still an impact on sales of the product and on the value of an investment in the company. 

The issue is not an easy one, but it is easy to see both sides of the argument.  On the one hand, a company should not need to respond to every unsubstantiated allegation, rushing to inform investors that it has irrationally been accused of something.  But conversely, this is a case where the concerns — even if perhaps not well nailed down statistically — are being raised by legitimate physicians on the basis of past, relevant research.  A transcript of the entire oral argument can be read here.

How the Court will ultimately decide the case is unclear because the facts are not clear-cut.  But the principles it will use are well-defined.  Companies are liable if they fail to disclose information that is considered “material” in that it will affect the value of the product and if they have failed to disclose that information with an intent to mislead.  Regardless whether the value that many consumers find in homeopathic remedies is substantiated, they deserve, as always, to have accurate information about what they are consuming.