The FDA Held A Hearing on Homeopathy and I got to Testify

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In April of 2015 it was announced by the FDA that they wanted to investigate the labeling of Homeopathic Products. On April 20th and 21st there was a two day hearing that was designed for the FDA to hear pros and cons about homeopathic labeling and the potential confusion to the public. I was honored to be the 5th presenter of 37 speakers at this two-day hearing. The setting of this hearing was quite pleasant from my perspective. There were approximately 170 people in attendance, 8 FDA commissioners and cameras to provide a live webcam for anyone who chose to listen. The majority of the speakers were wonderful and spoke highly of homeopathy and I have to say the professionalism of our profession was top notch and exactly what I would want it to be at such an event. The FDA tried to understand homeopathy, they asked fair questions and were very engaging with us. Never once did I feel undermined or condescended by questions they asked to me or to my colleagues. I was however, taken by surprise the media’s response.

 

What the media reported verses what was actually talked about in this hearing were two different things. The media painted a picture that the FDA was out to kill off homeopathy, shut it down and try to once and for all put an end to such medicine. It is an interesting emotion when it is your comments that are twisted or taken out of context from the media. For me the process restored some of my respect for the FDA, however, greatly damaged what all ready little respect I have for what the media reports. The media’s reports left the general public confused and angry at the FDA. The media has stirred up all kinds of anger that I don’t think at this point in the process is even remotely accurate.

 

The goal of the FDA is to keep people safe, limit confusion and make sure people are doing follows regulations. There is a lot of products on the market that will label themselves as “homeopathic” when in reality they are a supplement hiding under a few homeopathic remedies so they can make a different type of claim. Even worse there are products on the market that are labeled as “Homeopathic” that have never been homeopathic medications such as “HCG” or “IL4”. These products are sold to consumers thinking it is homeopathy when in reality those who know homeopathy know very well it is not homeopathic. The problem lays in the portion of the population who does not know how to tell the difference. This is the issue the FDA is trying to clear up, they are not trying to shut down homeopathy. If this was the message the media gave to the public the response would be far different. This was the conversation in the two-day hearing. The FDA is trying to understand homeopathy and trying to align themselves with experts in the field to keep homeopathy as it is intended to be. Below I have included the position I presented on behalf of the Homeopathic Academy of Naturopathic Physicians.

 

Testimony by the Homeopathic Academy of Naturopathic Physicians By Lisa Amerine, ND, DHANP April 20, 2015

Introduction: Thank you for the opportunity to speak today at this public hearing. My name is Lisa Amerine; I am a Naturopathic Physician and am board certified by the Homeopathic Academy of Naturopathic Physician (HANP) with diplomate status in Homeopathy. Since a very young age my life has been committed to homeopathy and for the past 11 years I have maintained a highly successful private practice exclusively dedicated to Homeopathy in Lafayette, Colorado. Currently I also sit on the board for the HANP and I am the HANP House of Delegates representative for the American Association of Naturopathic Physicians (AANP), in which I represent the specialty field of homeopathy. I am also a co-leader on what is known as the Materia Medica Pura Project, a collective 30,000 + hour project with the purpose of collecting any existing literature on each homeopathic medicine. This literature includes any proving publications, toxicology reports, and cured cases for every homeopathic medicine. This information is then compiled in one document, the “Materia Medica Pura” and serves as the most up to date information for homeopathic medicines. This on-going project insures that there is up to date and correctly referenced literature on every individual homeopathic medicine.

 

The Homeopathic Academy of Naturopathic physicians’ is a specialty field recognized with in Naturopathic Medicine. Naturopathic physicians lead our communities through out the US in natural health care. Physicians who specialize in homeopathy go over and beyond the already vigorous training received in homeopathy at naturopathic medical schools by undergoing further training in homeopathy. Upon completion of this process, which includes an additional board examination, they are awarded diplomate status. Practicing homeopathy is a true specialty in medicine and the diplomate status recognition rewards and acknowledges Physicians who have worked to achieve this status, setting them apart from any others who may be practicing homeopathy, thus Naturopathic Physicians with diplomate status in homeopathy are among the leading experts in homeopathy in the United States. The HANP also serves to further the excellence and success of homeopathy by providing continuing education that further sharpens the skill of not only the Diplomates but by physicians aspiring towards diplomat status. We also are committed to being an education resource for health care providers and the general public who may have questions regarding homeopathy.

 

Recommendations: HANP would like to respond to three particular questions posed by the FDA.

 

What are consumer and health care provider attitudes towards human drug and biological products labeled as homeopathic?

The licensed homeopathic medical professionals have a vast knowledge of the Materia Medica, which lists the properties of the medicines we use. This literature, when employed in conjunction with consideration of the unique totality of symptoms with which a patient presents, forms the basis for the accurate prescription of homeopathic medicines. Well-trained homeopaths will only prescribe based on these principles. Therefore, medicines labeled as homeopathic, regardless of their source – including human drug and biological products – will not be prescribed unless there is the proper literature found in the monographs to support the prescription. The homeopathic health care professionals, especially those with diplomate status have very busy practices. Frequently we will train our patients regarding basic homeopathic medicines that they can purchase over the counter to take care of simple non-dangerous conditions like an acute cold. The consumers love this because they can try some basic things at home that are often very effective, safe and inexpensive to use. The health care provider likes this because it empowers the patient and leaves time for the physician to treat more serious conditions.

 

Are there areas of the current CPG that could benefit from additional clarity? If so, please explain.

The HANP serves to further the excellence in homeopathy by providing resources and continuing education for providers and the community. In an attempt to further the excellence in homeopathy the HANP believes that FDA’s CPG Sec. 400.400 Conditions Under Which Homeopathic Drugs May be Marketed, needs some clarification. For example: 1. Definition number 2 states, “Drug products containing homeopathic ingredients in combination with non-homeopathic active ingredients are not homeopathic drug products.” While the definition is clear, there is a loop hole that many products are taking advantage of. This loop hole provides manufactures the opportunity to put a substance in the “inactive” category while leaving the list in the active ingredients listed as HPUS homeopathic remedies that meets definition 2 per the FDA document. These inactive ingredients added are not always stabilizers but often a dietary supplement such as tea tree oil or aloe vera. This allows for manufactures to put products on the market and make an OTC drug claim when otherwise the product would be limited to a dietary supplement status. When this is done the product should not be considered a homeopathic drug, nor should be allowed to be marketed as such. The HANP believes this issue is a good example of where additional clarification could be helpful.

 

Do consumers and health care providers have adequate information to make informed decisions about drug products labeled as homeopathic? [If not, what information, including, for example, information in labeling, would allow consumers and health care providers to be better informed about products labeled as homeopathic?]

The Homeopathic Academy of Naturopathic Physicians serves to provide quality education not only to other health care professionals but also to the lay public. Physicians, in particular, those with diplomate status are on the front lines of homeopathic health care and daily field questions from the consumer and from other health care providers regarding homeopathic products. These experts, because of their extensive knowledge of homeopathy can easily provide information regarding products, which are labeled as homeopathic and comment knowledgably as to their efficacy and safety. There are many health care providers and consumers who know very little about homeopathy. Our goal with in the HANP is to be able to provide these people with quality information that can help guide them. Therefore the suggestion of the HANP is to maintain a team within the FDA that consists of experts in drug regulation, representative(s) of the American Association of Homeopathic Pharmacists (AAHP) and the Homeopathic Pharmacopoeia Convention of the United States as well as an expert clinical physician with diplomate status who is on the front lines of homeopathic health care and who is also committed to providing quality education to the public. A team comprised of such experts in the field is vital and will be able to help clarify any questions as to homeopathic labeling and most importantly help to ensure the safety of the consumer.

 

In closing today I would like to end with a story, 150 Years ago on a journey across the country on the Oregon Trail a group of explorers got stuck in the Cascade Mountains due to bad weather. They had to abandon their wagons and finish the trip on foot. They chose to bury their most valuable possessions so they could return to them when conditions were more favorable. Amongst one of those things buried was a small book written by a homeopathic physician, Constantine Hering, titled “The Homoeopathic Domestic Physician” and a small homeopathic medicine kit. For these people and people since then, homeopathic medicines have been effective and safe to use at home if their condition was intense enough to need attention but not severe enough for the care of a physician. There are many books such as this book that still guide the consumers in the lay public about making informed decisions regarding drug products labeled as homeopathic. Because homeopathy is safe and it is fairly easy for the consumer to understand what to buy should they have a minor health ailment, the HANP highly encourages that these homeopathic medicines continue to be available over the counter because they are so effective for helping improve the health of the population. Thank you for your time and consideration

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