Communicating about bioterrorism and epidemic disease

June 21, 2006

from "Quicktips" published by the American Association of Homeopathic Pharmacists (AAHP)

The anthrax and related bioterror scares have put quite a strain on the information resources of the homeopathic industry. The following was developed by the AAHP in conjunction with physician members of the American Institute of Homeopathy, the National Center for Homeopathy, the Homoeopathic Pharmacopoeia of the United States and our AAHP Counsel.

1. When properly applied by trained medical professionals, homeopathy has been shown to be useful in epidemic disease. The approach taken has been to rapidly observe the symptoms manifested in the population and to match them to the homeopathic medicine(s) that have that symptom picture. The medicine(s) chosen are called the genus epidemicus. Historically, the genus epidemicus has been a broad acting drug (polychrest). For example, in the flu pandemic of the early 20th century, the genus epidemicus was the homeopathic medicine gelsemium. Consumers should be made aware that this approach (the normal homeopathic approach of case taking) has been shown to be successful.

2. What about nosodes? Nosodes are defined as "homeopathic attenuations of: pathological organs or tissues; causative agents such as bacteria, fungi, ova, parasites, virus particles, and yeast; disease products; excretions or secretions. Nosodes are prepared according to homeopathic specifications, provided the basic substance is not altered and the final product is not adulterated by pathogens or other deleterious substances. The first attenuation must be rendered sterile..." Many consumers are requesting the nosodes anthracinum (made from the sterile lysate of liver of a rabbit infected with bacillus anthracis) and variolinum ( source indeterminate). The nosode approach in epidemic disease is not well documented. For the pharmacist and manufacturer, the issue raises several important areas:

a. Compendiality. Nosodes included in the Pharmacopoeia include: Anthracinum (Anthrax), BCG, Candida Albicans, Candida Parapsilosis, Colibacillinum, Hippozaeninum, Influenzinum, Lyssin, Medorrhinum, Morbillinum, Pertussinum, Proteus, Psorinum, Pyrogenium, Sinusitisinum, Staphylococcinum, Streptococcinum, Syphylinum, Tuberculinum, Tuberculinum Bovinum, and Vaccinotoxinum, These medicines have well defined source materials in the literature as well as standardized methods of preparation. Whether the HPCUS recommends any attenuation of these medicines for non-prescription sale depends on the primary clinical indication. Those nosodes used for chronic conditions are typically restricted to prescription-only sale, while those that have OTC indications are not so restricted.

Curious by its absence in the HPUS is Variolinum- the smallpox nosode. Variolinum has never been approved by the HPCUS because, although there is extensive clinical literature on the use of the medicine, there are no conclusive data on the starting material which was subsequently proved and used in the development of the literature. In other words, although we have information in the literature on a substance(s) called Variolinum, HPCUS was not able to determine with certainty just what the substance source material actually was.

The issues relating to official and non-official homeopathic drugs have been discussed in a previous Quick Tips article. Suffice it to say that should the manufacturer sell non-compendial products, s/he is required to justify the label claims to the satisfaction of FDA.

b. Claims. Label claims will determine the OTC/Rx status of the homeopathic product. For a product to be non-prescription, the claims must be made for symptoms of conditions that are self-limiting and do not require medical diagnosis or monitoring. Most infectious diseases fall outside the area of non-prescription status; because an absolute confirmation of infection with a particular disease-producing microorganism requires laboratory tests. The status of the product will depend on the individual label, however, the AAHP counsel notes that even implied claims put the manufacturer at regulatory risk. For example, although Anthracinum HPUS can be sold OTC for vesicular eruptions (Boericke), if the manufacturer even implies that the product can be used for infectious disease they may have a violative product.

Consequently, counsel advises that manufacturers affirmatively inform consumers that the products are NOT intended for infectious disease. An example of such a disclaimer is:

"Included in this shipment is homeopathic Anthracinum. We want you to know that Anthracinum is monographed in the Homoeopathic Pharmacopoeia of the United States and may be sold OTC for appropriate OTC indications. Anthracinum from X Company is labeled for relief of symptoms of vesicles and skin eruptions . Please note that the literature does not support, nor is the product labeled for, use as either prophylaxis for or treatment of infections caused by bacillus anthracis (anthrax). Such indications are prescription in nature and are an inappropriate use of this product. If you believe that you require prevention of, or treatment for symptoms of infection caused by bacillus anthracis, please see a licensed health care provider immediately. Please see our website www.xcompany.com for more information, or the website of the National Center for Homeopathy at www.homeopathic.org."

c. Prophylaxis. The use of homeopathic medicine for the prevention of disease is controversial and not well supported in the literature. In addition, the FDA considers homeopathic 'vaccinations' to be violative. The following is an excerpt of an official FDA correspondence to HPCUS in May 1997:

"This letter is sent regarding our recent conversation concerning products claiming to be homeopathic nosodes that are intended to prevent various diseases through vaccination, including childhood diseases such as measles, mumps, rubella, pertussis, diptheria, polio, tetanus, etc.

It appears to us that such products can not be defined as homeopathic when intended to prevent disease through vaccination. This position is based on the fact that such substances, again when used for preventing disease through vaccination, are not being administered for healing the sick, as the definition of homeopathy requires. The individual being treated is not sick at the time the drug is administered. Further, they are not in keeping with the basic tenet of homeopathy, that is 'similia similibus curentur', since they are not be offered to 'cure a like' but to prevent a disease."

This statement speaks for itself and makes abundantly clear FDA's position on the use of homeopathic medicines for prophylaxis.

3. Communicate with your customers. As you know, American consumers crave information. Open communication is always helpful. The National Center for Homeopathy is publishing original articles and information at www.homeopathic.org. NCH is glad to share the information and will be glad to be linked to an AAHP member's website. Please contact them directly to create such a link.

Remember, although homeopathy has been shown to treat symptoms of infectious and epidemic diseases, Federal law prohibits the sale of products for these symptoms as OTC products. Accordingly, the AAHP makes clear its position that websites and marketers selling homeopathic medicines as OTC products for epidemic and infectious diseases may be in violation of Federal law. AAHP hopes that these QuickTips are useful. If you have questions, comments or ideas, please feel free to communicate them to the Board of the AAHP or the Legal and Regulatory Affairs Committee.