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Is the FDA acting out of malicious intent or willful ignorance in publishing a new draft guidance on homeopathics which would effectively treat them like pharmaceutical drugs, with similar regulatory requirements?
FDA's Regulatory Overreach Reflects Poor Understanding of Homeopathy
When FDA announced a “draft guidance” in December 2017 stating its latest intentions regarding the regulation of homeopathic products, it became clear that the agency had paid little attention to the concerns of the homeopathic community of practitioners, consumers, patients, and manufacturers. It turns out that the FDA’s public hearing held in 2015—during which numerous representatives of homeopathic interests from across the U.S and around the globe gave overwhelmingly positive testimony as to the safety, efficacy, and unique nature of homeopathic medicines—was just a pretense designed to give the appearance that it was taking the public’s concerns into account.
Hiding behind rhetoric emphasizing concerns for the safety of consumers—“FDA is proposing a new, risk-based enforcement approach to homeopathic drug products that have the greatest potential to cause risk to patients”—FDA is intending to launch a two-pronged initiative that exaggerates the risks associated with homeopathic products and denies the existing evidence in support of their safety and effectiveness.
Regarding the Safety of Homeopathic Medicines
FDA has chosen to use a very small number of unsubstantiated accounts of adverse events supposedly associated with homeopathic products in order to justify overregulation of the industry as a whole. Failing to acknowledge that the current regulatory framework, Compliance Policy Guide 400.400 (adopted in 1988), is more than sufficient to accomplish its stated goal of protecting the public from potential harm, FDA appears bent on tearing that policy down in favor of either a new and unnecessarily stringent policy or no replacement policy at all.
No policy at all would likely result in confusion about FDA’s expectations of homeopathic manufacturers and could provide opportunity for FDA to exploit the lack of clear regulatory bounds. Ronald Whitmont, MD, President of the American Institute of Homeopathy (AIH), echoes this sentiment:
"What is clear is that FDA has ignored the homeopathic community’s requests to update this guidance. By withdrawing CPG 400.400 the FDA is removing the only clear guidelines that have served to help the FDA, the homeopathic manufacturers, and the public to understand the policies surrounding the marketing and labeling of homeopathic products.
The AIH is very concerned that the withdrawal of this document will create a situation where anything can be labeled “homeopathic” and muddy the waters around what actually is homeopathic. The AIH is also concerned that withdrawal of the guidance would allow the FDA to act capriciously and to interpret the new guidelines more broadly than they should be.
If the FDA is unhappy with the current CPG 400.400 we advise that they amend it to make it a better, more comprehensive guideline, not one with less clear instructions that could result in abuses from both manufacturers and regulators. Only the public will suffer when this happens."
I have written previously about FDA’s trumped-up scare tactics regarding homeopathic teething tablets. For decades, homeopathic medicines have been subject to unrelenting criticism from mainstream science and conventional medicine. Critics contend that the quantities of ingredients used are too small to have any physiological effects and, all observed effects must, therefore, be written off as placebo effects. In other words, the predominating belief is that homeopathic doses are too small to be of any health concern.
Astonishingly, we are witnessing a suspicious about-face whereby homeopathic medicines have apparently morphed overnight in the minds of FDA officials from useless placebos to dangerous toxins. Although the scientific community is talking out of both sides of its mouth, it can’t have it both ways. Truth be told, any qualified homeopathic doctor will tell you that neither assertion is the case. While homeopathic medicines are clearly not placebos, they are also nothing like conventional pharmaceuticals.
Homeopathic medicines are in a class completely on their own, which is why when homeopathic physician and New York State Senator, Royal Copeland, MD, sponsored legislation creating the Food, Drug and Cosmetic Act of 1938, it was abundantly clear to the U.S. Congress that homeopathic products did not pose a risk and did not warrant the type of scrutiny that the modern-day FDA now claims it deserves.
Although the safety profiles of homeopathic medicines are unparalleled, FDA wants you to believe otherwise. A handful of isolated and unproven cases of seizures supposedly caused by homeopathic Belladonna elicited a “warning against the use” of teething tablets and a thorough review of FDA’s oversight of the entire homeopathic industry.
By contrast, here is a list of 200 drugs admittedly known to be able to produce seizures as possible side effects. I don’t see FDA clamoring to warn people against using these drugs. And I certainly don’t see them undertaking an audit of the entire pharmaceutical industry. When the safety of homeopathic products is compared against the track records of almost all conventional pharmaceuticals, FDA’s egregious double standard becomes unavoidably apparent.
If you understand homeopathy and you’ve seen it work, you know that safety is a virtual non-issue. If a remedy is manufactured according to standards of the Homeopathic Pharmacopeia of the United States (HPUS), there is no reason for concern and no need for FDA to think it would need greater oversight. Therefore, the only way a homeopathic medicine can cause harm is if it has been manufactured recklessly in a manner that does not follow proper protocol. A properly made homeopathic dilution, by definition, cannot be toxic because the degree of dilution is too great. For FDA to believe otherwise is unscientific and disingenuous.
Another completely specious contention that FDA makes in its draft guidance is that homeopathic treatment “may cause users to delay or discontinue medical treatments that have been found safe and effective.” This is a classic anti-homeopathy activist talking point, one that makes a number of bogus assumptions, and one that is inherently defamatory of the homeopathic medical profession. It implies that homeopathic treatment is inferior, that it does not constitute safe and effective treatment, and that turning to conventional allopathic drug therapy is always the superior, safe, and effective thing to do.
There is no possible justification for such a statement given that one Johns Hopkins study concluded that medical error is the third leading cause of death in the U.S., a number that represents more than 250,000 deaths per year. And FDA wants to ratchet up regulation of homeopathy due to a few uncorroborated case of seizures from one homeopathic product? Something smells very fishy, indeed.
The Homeopathic Industry Agrees That Safety Standards Are Needed
Now, it is true that unscrupulous parties have been known to market so-called homeopathic products that don’t follow proper manufacturing guidelines as set out by the HPUS or don’t adhere to “current good manufacturing practices” (cGMP). If and when that happens, FDA already has the regulatory authority to effectively handle such infractions. As such, there is no need to make any changes in regulatory policies regarding homeopathic products. Nevertheless, FDA appears ready to jump the shark, giving the clear but erroneous impression that homeopathic products have suddenly become a safety concern.
The homeopathic industry does not disagree with FDA regarding the need for safety standards. However, it objects to the need for revised standards that place homeopathic products at risk for overzealous and punitive regulatory actions. Current FDA policy as stated in Compliance Policy Guide 400.400 is both adequate and effective. Eric L. Foxman, R.Ph., Secretary of the American Association of Homeopathic Pharmacists, is rightfully concerned, and has this to say about FDA’s proposed actions:
"In its apparent zeal to address problematic products, the FDA has decided to do away with the existing regulatory framework under which the industry and the agency have worked together for over 25 years. This is poorly considered and ill advised. In fact, without some of the aspects of the existing Compliance Policy Guide, many more problematic homeopathic products could conceivably be brought to market. This could lead to the marketing of more adulterated, misbranded or fraudulent products masquerading as homeopathic. That would be an abdication of FDA’s role as a public heath agency, and would be a giant step backwards for homeopathy and, especially, the American consumer."
Although the homeopathic manufacturing industry has tried to maintain a good faith relationship with FDA, the agency, in my opinion, has not acted in kind. Historically speaking, the two parties once did have a good working relationship, but this has not been the case for decades.
Regarding the Purported Lack of Evidence in Support of Homeopathy
FDA’s announcement and its new draft guidance statement make repeated references to the “unproven” nature of homeopathic medicines. Emboldened by another agency that also has little knowledge of homeopathic medicines, FDA makes reference to FTC’s claim that, “companies must have competent and reliable scientific evidence for health-related claims, including claims that a product can treat specific conditions.”
Here, in direct violation of the spirit of an act of Congress that created the Food, Drug and Cosmetic Act, the modern FDA appears to be setting the stage for the possibility of removing the special status of homeopathic medicines. This would give them the same status as conventional drugs, potentially subjecting them to the same regulatory approval process.
This would likely bankrupt the industry, since homeopathic drugs would not be able to command the same outlandish prices that conventional pharmaceuticals have used to gouge the public and to pay for the exorbitant costs of the drug approval process. It amounts to a form of organized governmental crime that only the most obscenely wealthy companies can afford.
(I would like to make clear that this is not the opinion of the homeopathic manufacturers. They do not interpret FDA’s intent in the same conspiratorial way as do I and some others. They are of the opinion that FDA is looking to do its job to protect the public, and not out to undermine homeopathy. It is also important to note that while FDA’s actions could impact the manufacture and marketing of certain homeopathic products, it has no jurisdiction over those who practice homeopathic medicine.)
This brings us to the critically important issue of what it is that actually constitutes scientific evidence. First and foremost, I must state with unequivocal certainty that any claim that there is a lack of research evidence to support homeopathy is an absolute falsehood. Those who make such claims are either deliberately lying, are repeating bogus talking points that they have read or heard elsewhere, or do so out of pure ignorance. There are literally thousands of research trials, many of which shine favorably upon homeopathy. To examine the evidence and then deny its existence is to be deliberately obtuse.
Dr. Samuel Hahnemann developed his system of treatment by similars 200 years ago by studying the effects of his diluted medicines on healthy test subjects. FDA acknowledges this methodology, which Hahnemann called “proving.” It is an inherently safe process that involves using highly diluted medicines that are incapable of producing toxic effects. Diluted medicines are made, they are proven on test subjects, and the resulting information is used as a guide to treat people with symptoms that match the symptom patterns of the remedy provings. There is good reason to believe that it was Hahnemann himself who conducted the very first placebo-controlled, blinded research trials.
In addition to provings and modern research trials, homeopathy also has a vast body of clinical literature that dates back 200 years. Included in the literature, which was written almost exclusively by experienced physicians, are thousands upon thousands of clinical case studies. Physicians painstakingly documented the patients they encountered, the symptomatic presentation of their complaints, the remedies administered to them, and the short and long term outcomes of treatment. This process continues to this day, with countless case histories having been published in numerous international homeopathic journals both new and old.
What happens when we try to evaluate homeopathic products according to conventional pharmaceutical research standards? What all homeopathic practitioners understand—and FDA does not—is that successful homeopathic treatment is critically dependent upon context. It is not possible to get reliable results by choosing a target symptom or two to treat in isolation from all other symptoms of the patient. This type of symptomatic focus is the very thing that defines allopathic medicine. In contrast to a conventional cough suppressant drug, for example, there is no such thing as a homeopathic remedy that can be used to treat coughs in general. Each cough is unique and must be treated accordingly.
For example, Drosera is a well-known remedy for coughs of a specific type. It is especially suited to violent coughing paroxysms that can result in vomiting and even nosebleeds. The attacks are more likely to flare up after midnight. Pulsatilla, on the other hand, suits coughs that are much less aggressive. The cough gets worse when lying down, forcing the person to sit up to get relief. The person who needs Pulsatilla also complains of feeling worse in a warm room, needs fresh air to feel better, and experiences a noticeable decrease in thirst. Spongia is a remedy suited for hoarse, dry coughs. There is often tickling in the throat, which can be quieted by drinking warm drinks.
This is just a small sample of potential homeopathic cough remedies and their unique characteristics. While these types of details have little to no bearing on conventional drug therapy choices, they are crucial factors that determine successful homeopathic prescriptions.
Now imagine what would happen if FDA required a study to “prove” the value of Drosera in treating coughs. Of 100 test subjects, how many do you think would fit the criteria to justify a prescription of this particular homeopathic medicine? Very few, indeed. How long would it take to find 100 test subjects that do have symptom patterns that match Drosera? I suspect it would take years even under the best of circumstances.
Furthermore, although Pulsatilla is well-indicated for certain types of coughs, it can also be used it to successfully treat a wide spectrum of health problems, including hot flashes, ear infections, gallbladder attacks, eczema, depression, and many more. Unlike most pharmaceutical drugs, homeopathic medicines do not have single indications. They have many uses. This basic truth adds even further confusion to FDA’s already poor understanding of homeopathic products.
So when FDA demands proof of homeopathic effectiveness according to conventional medical standards, the deck is already stacked against any prospect of success. Conventional drug trials are very poorly suited to understanding the benefits of homeopathic medicines. Each homeopathic medicine has many potential therapeutic indications, and there are many potential homeopathic remedies that can help the various individuals diagnosed with the same illness.
The irony here is that FDA requires a homeopathic label to include a specific indication for its use, and then asks for proof that it can help that condition. FDA is under the false impression that it can treat homeopathic products as if they are no different from allopathic drugs. Furthermore, FDA’s latest draft guidance states the following:
Generally, a drug, including a homeopathic drug, is considered a “new drug” if it is not generally recognized as safe and effective (GRAS/E) by qualified experts for use under the conditions prescribed.
Although this guidance clearly implies that FDA should consult qualified experts when making judgments regarding homeopathic medicines and their uses, there are no such experts on FDA’s staff. Neither does FDA have any ongoing official working relationships with outside experts in spite of requests from the homeopathic community that FDA fulfill this obligation. FDA lives in an allopathic bubble with no conception of the true nature of homeopathic products, how they work, or how they should be regarded. It is clear that FDA just doesn’t get it; it has little understanding of how homeopathy works or how it should be evaluated.
There are only two plausible explanations for FDA’s misguided attitude toward homeopathy. One is that it is acting with malicious intent to undermine the homeopathic industry, and to subvert an act of Congress, in which case it would not be far-fetched to assume that they are being encouraged to do so by Big Pharma, which is the one party that stands the most to gain from this fiasco. Given FDA’s multiple references to the recent growth of the homeopathic market, this is not an unreasonable conclusion.
The other explanation is that FDA is acting out of willful ignorance. They act like they are listening but their minds are closed. Notwithstanding the possibility of good intentions to guard the public safety, FDA’s actions reveal that it has a very poor grasp of homeopathy, and it does not seem interested in learning from true homeopathic experts.
So what is the best way to study the effects of homeopathic medicines? In terms of conventional research methodology, the protocol most suited to studying homeopathy is one that treats each individual according to his or her unique symptom pattern. It would involve treating a particular disease category, such as ear infections for example, with as many different remedies as are needed to treat the various individuals involved in the study. Each case of ear infection would receive the single remedy that best matches its symptomatic expression. It might require 10, 15, 20 or more different remedies in order to properly treat all of of kids in the study. Of course, this does not satisfy FDA’s conception of a properly conducted research trial. Nevertheless, it is the only way to give homeopathy a fair shake.
As far as homeopaths are concerned, the types of evidence best suited to homeopathy are provings and case studies as previously described. Ironically, and perhaps conveniently for disbelievers, this is the type of evidence that modern medicine now derisively calls “anecdotal.” Medical science has devolved to a point where it trusts the statistical trickery of research trials that evaluate only a few limited parameters (such as the ability to suppress a cough) more than it trusts the first-hand experiences of patients and their doctors (case studies).
Modern standards of medical evidence are badly out of kilter. The first step in rectifying the imbalance will be for medicine to acknowledge the truth of the safety and effectiveness of homeopathy and the many lessons that it has to teach about health and healing.
We Must Continue to Stand for Freedom of Medical Choice
Here’s what you can do…
1. One way to help right now is to submit positive comments (not criticisms of FDA) to FDA in support of homeopathy. Tell FDA that its current regulatory guidelines (Compliance Policy Guide 400.400) for homeopathic products are more than adequate and that any further changes place your right to choose in jeopardy. The period for public comment before FDA makes its final decisions about this critically important policy closes on March 20, 2018. (Comment here)
2. The Homeopathic Pharmacists of the United States also urge those who live in certain states (CO, NM, PA, TN, WA, UT) to urge their legislators to tell FDA not to scrap the current guidelines regarding the regulation of homeopathic products. All you have to do is sign your name to the letter. Even better if you add your own personal story of homeopathic success. (Take Action Here)