Position Statement from the American Association of Homeopathic Pharmacists (AAHP) Regarding Hurley Publications
In the book “Natural Causes: Death, Lies, and Politics in America’s Vitamin and Herbal Supplement History” (Broadway Books / 2006), author Dan Hurley presents data from the American Association of Poison Control Center’s (AAPCC) National Poisoning and Exposure Database. Within the book and an essay authored by Hurley in the January 16th, 2007 edition of the New York Times, the author claims that:
• The AAPCC database has recorded 1.6 million reports of ‘adverse reactions’ to supplement products (vitamins, minerals, essential oils, herbal products, homeopathic products, etc.) from 1983 to 2005.
• There were 7,049 ‘reactions’ to homeopathic products reported to the AAPCC database in 2005. This was the ‘most reports of reactions…among herbs and other specialty products’.
• 10.3% of the ‘reactions’ to herbal products, homeopathic products, and other dietary supplements occurred when the patient took the recommended amounts of product, a percentage threefold higher than seen with traditional medications such as asthma drugs, painkillers, and cough and cold preparations.
Hurley has used these data to suggest that there is strong evidence that some complementary and alternative medicines (including homeopathic products) carry risks of injury or death, and that children may be particularly vulnerable. These “findings” were profiled in a segment of the CBS Evening News in February 2007.
The American Association of Homeopathic Pharmacists (AAHP), representing the major manufacturers and distributors of homeopathic drugs, treats any reports questioning the safety of homeopathic products with the utmost concern. At the request of AAHP, an independent examination of the data presented in the book and the New York Times essay was conducted by Dr. Joshua J. Spooner, Director of Clinical and Outcomes Services at the University of the Sciences in Philadelphia (USP). A closer examination of the data shows that in several instances the author mischaracterized the nature of the data that he reported.
• The author characterizes each report in the AAPCC database as a ‘poisoning’ or ‘reaction’, when in fact neither term is accurate. Each report represents an exposure, defined by the AAPCC as a non-administrative, non-information call where the caller was concerned about an exposure to a substance.
- To define each call as a poisoning or reaction is improper, as the patient may not have developed any adverse signs or symptoms related to ingestion. For example, a concerned parent who calls a poison control center because his or her child took more than the recommended dosage of a homeopathic product is counted as an “exposure,” even if the poison control center informs the parent that the product is nontoxic and that there is no cause for concern. In the 2005 database, 33.3% of exposures were categorized as having no effect or as being non-toxic, and an additional 38.5% of exposures were categorized as having a minimal risk of toxicity with no need for follow-up by the regional poison control center. Thus, in 2005, over 70% of the reports in the AAPCC database that the author classified as a ‘poisoning’ or ‘reaction’ resulted in no effect, were non-toxic, or had a minimal risk of toxicity.
- A correction to Hurley’s New York Times article was published on February 6, 2007 describing the proper context of an exposure versus a poisoning or a reaction. The correction noted that of the 7,049 exposures to homeopathic products reported in 2005 by AAPCC, only 178 (2.5%) of these resulted in adverse reactions.
• The statement that homeopathic products were responsible for the most reports of ‘reactions’ (exposures) among herbs and other specialty products is strongly influenced by the nature of data categorization within the AAPCC database. The AAPCC groups all homeopathic products together into a single category in its annual report, and does not provide a breakdown of the number of exposures for individual products (as it does for vitamins, cultural medicines, botanical products, electrolytes and minerals, and essential oils). If all of the herbal products were grouped together into a single category in a similar manner to the homeopathic products, the number of herbal product exposures in 2005 would total 9,652, a number that exceeds the number of exposures for homeopathic products by over 25%.
• The statement that 10.3% of ‘reactions’ (exposures) reported to the AAPCC for herbal products, homeopathic products, and other dietary supplements occurred when the patient took the recommended amount of product (i.e., a true adverse reaction) is best examined by separating out the components that were compiled to produce this value. When examined separately, the percentage of exposures due to adverse reactions was far lower for homeopathic products (2.5%) than the other components of this grouping, including hormonal products (4.8%), botanical [herbal] products (15.6%), cultural medicines (17.3%), and amino acids (18.4%).
- Further, the percentage of exposures due to adverse reactions for homeopathic products was comparable to that for vitamins (3.1%) and minerals and electrolytes (2.4%), and was less than what was observed for traditional medications for asthma (3.6%), painkillers (3.5%), and cough and cold preparations (3.1%). “These findings suggest that, at the very least, the evidence used by Hurley to demonstrate a risk of injury with homeopathic products was misinterpreted,” said Dr. Spooner. “The percentage of telephone calls to poison control centers attributable to adverse drug events was actually lower for homeopathic products when compared to some common classes of traditional medicines. To state that homeopathic products have a higher risk of injury than traditional medicines is inaccurate.“
In November 2007, USP researchers commenced an independent, retrospective analysis of the AAPCC database. In this study, information on all exposures involving homeopathic products from 2001 through 2006 will be collected and analyzed in order to understand the nature of the exposure, the clinical effects related to the exposure, and the medical outcome of the exposure. Support for this research is being provided by AAHP through an unrestricted research grant and demonstrates AAHP’s commitment to providing consumers with safe, reliable, and efficacious homeopathic products.