Edward De Vere.  Sort-of.

Friends, FDA, countrymen, lend me your ears;

I come to bury Homeopathy, not to praise it.

The evil that homeopaths do lives after them;

The good is oft interred with their bones;

So let it be with Homeopathy. The noble Ullman

Hath told you homeopathy was effective:

If it were so, it was a grievous fault,

And grievously hath Homeopathy answer’d it.

Here, under leave of Ullman and the rest–

For Ullman is an honourable man;

So are they all, all honourable men–

Come I to speak in Homeopathy’s funeral.

It was my nostrum, faithless and worthless to me:

But Ullman says it was effective;

And Ullman is an honourable man.

He hath brought many provings home to HPUS

Whose prescriptions did the general coffers fill:

Did this in Homeopathy seem effective?

When that the ill have died, Homeopathy hath wept:

Efficacy should be made of sterner stuff:

Yet Ullman says it was effective;

And Ullman is an honourable man.

You all did see that on the Cochrane

I thrice presented Homeopathy a meta-analysis,

Which he did thrice refuse: was this efficacy?

Yet Ullman says it was effective;

And, sure, he is an honourable man.

I speak not to disprove what Ullman spoke,

But here I am to speak what I do know.

Edward De Vere, 17th Earl of Oxford. Sort of.

We only have a vague idea as to what other bloggers are going to write about. Yesterday Jann wrote on the same topic (and Scott the week before), which I will read tomorrow after my post goes up. Why would I want my post to be informed by another’s well-reasoned and thoughtful essay? I have a reputation after all. So here is my response to the FDA.

I am writing in response to the request for recommendations concerning the regulation of homeopathic nostrums by the Food and Drug Administration (FDA).

I recognize that because of federal law the FDA has significant handicaps in the regulation of homeopathic nostrums since the Food, Drugs and Cosmetics Act of 1938 defines as a drug any product found in the US Homeopathic Pharmacopoeia (HPUS).

As a result of the Act, any nostrum in the HPUS is considered a legal medication in the US. The only premarketing evaluation required for a homeopathic nostrum is to find its way into the HPUS. Inclusion in the HPUS is usually by a homeopathic proving, a form of evaluation that does not prove either the safety or the efficacy of the nostrum.

So despite the fact that homeopathy is based on prescientific vitalism that is divorced from a modern scientific understanding of health and disease, homeopathy is protected from meeting the same standards of safety and efficacy that real medications must meet. I recognize that true, substantive regulation of homeopathy, requiring homeopathy to meet the same rigorous scientific medical standards as real pharmaceuticals, will require Congress to change the current laws governing the homeopathy.

Since homeopathic products contain no active product and have no effect on any disease or physiologic process, the need to remove a homeopathic product because of safety issues or serious side effects, such as happened with ephedra in 2004, is unlikely. Containing only water and/or sugar, homeopathic products are unlikely to suffer from issues of contamination and poor production quality that have been common with herbal and dietary supplements.

The major medical problems from homeopathy come from using the nostrums in lieu of effective medical therapies. Taking homeopathic nostrums for diseases such as asthma, meningitis, and malaria can have fatal consequences:

Moreover, some deaths were associated with “corticophobia,” with many patients preferring to use homeopathy or acupuncture.

One of many examples of relying on homeopathy resulting in death or serious illness. But it is a difficult scenario to regulate.

What then can and should be done to regulate homeopathy? Much of the use of homeopathy comes from a lack of transparency as to how homeopathic products are made and what they contain. To answer some of the questions asked by the FDA.

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

Many consumer think homeopathic products are the equivalent of herbal, vitamin, or other types of supplements. They are surprised and often express disbelief when the true nature homeopathic preparations and its dilutions are explained. Most people are unaware of what homeopathy is and homeopaths are not forthcoming with explanations.

What data sources can be identified or shared with FDA so that the Agency can better assess the risks and benefits of drug and biological products labeled as homeopathic?

The Science-Based Medicine blog (http://sciencebasedmedicine.org) has extensive reviews on homeopathy and the medical literature. Examples of the dire consequences of relying on homeopathy instead of science-based medicine can be found at the websites “What’s the Harm?” (http://whatstheharm.net/homeopathy.html) and “Discover Homeopathy” (http://discoverhomeopathy.co.uk/victims–2/).

Is there information regarding the regulation of homeopathic products in other countries that could inform FDA’s thinking in this area?

The best reviews on the complete lack of efficacy are the UK and Australian systematic reviews. They clearly demonstrate that there are no well-conducted clinical trials that demonstrates homeopathic nostrums have any effect on any disease. There is also the Swiss report on homeopathy. However, as noted by neurologist and Science-Based Medicine founder Steven Novella:

The Swiss report, which was favorable to homeopathy, was a reaction to a previous Swiss decision against homeopathy. The committee was packed with homeopaths, and not surprisingly they put a positive spin on the review.
If you analyze the review you find that actually they came to the same conclusion about the data – that high quality studies show that homeopathy does not work. Then, however, they pulled a trick. As I previously reported:

The Swiss study looked at the same data, but apparently wanted to come to a favorable conclusion. So they argued for a change in the normal rules of evidence, a common strategy among CAM proponents. They decided to rely more on “real-world effectiveness,” which is just CAM newspeak for “poorly controlled studies.” In the real world we cannot control for variables and blind subjects – those are artificial conditions of rigorous trials.

The Swiss report was rigged and biased, and yet they still could not conclude that the data shows homeopathy works. They had to pull the “placebo medicine” gambit and claim that it sort of “works” even though there is no real effect from homeopathic products. Only homeopaths were apparently fooled by this ploy.

A large majority of human drug products labeled as homeopathic are marketed as OTC drugs. These products are available for a wide variety of indications, and many of these indications have never been considered for OTC use under a formal regulatory process. What would be an appropriate regulatory process for evaluating such indications for OTC use?

For OTC designation, at a minimum homeopathic should meet the same safety and efficacy as any other medications. Unlike most OTC medications, homeopathic nostrums are offered as treatments for potentially life-threatening diseases, from measles to whooping cough. Since homeopathic medications have no proven efficacy for any disease they should not be sold as OTC medications.

Allowing sugar and water to be sold as a treatment for serious illnesses and placing them next to medications with proven efficacy in drug stores gives the nostrums an undeserved credibility. Efficacy by association is not in the best interest of consumers.

Given the wide range of indications on drug products labeled as homeopathic and available OTC, what processes do companies currently use to evaluate whether such 8 products, including their indications for use, are appropriate for marketing as an OTC drug?

As an OTC product, homeopathic nostrums should meet the same standards of safety and efficacy as other medications. Patients will often turn to homeopathic products instead of seeing their doctor because see a physician costs both money and time and the homeopathic products are often less expensive. So if a patient is deciding to use a homeopathic product to treat their asthma or diabetes, it is imperative the product should have efficacy. Homeopathic nostrums never meet this criteria.

And although the FDA is not responsible for the ethics of homeopathic medications and prescribing, it is clear that selling a product that contains no active product and can have no efficacy is unethical. To quote retired physician and professor of Complementary Medicine at the University of Exeter, Edzard Ernst:

It should be axiomatic that ethics is indispensable to the practice of medicine, and is not something that can just be switched off at will. No branch of health care, including alternative medicine, can be considered exempt from it. But the subject of ethics is seldom even considered in alternative medicine; many alternative practitioners have never been taught medical ethics, and where training in this area does exist, it tends to be at best superficial…It is perhaps not surprising, therefore, that the principles of medical ethics are routinely ignored and frequently violated by promoters of alternative medicine…Medical ethics seem to me to be violated, for example: when homeopaths prescribe or recommend homeopathic vaccinations for which there is not a shred of evidence;

Selling homeopathic nostrums violates the first rule of medical ethics, that of beneficence. Physicians are expected not only to refrain from causing harm, but they also have an obligation to help their patients. Homeopathic nostrums accomplish neither.

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 labels on homeopathic nostrums work to obscure the true nature of the product. As an example, the label of Oscillococcinum, a popular homeopathic preparation sold as a flu remedy, says it contains Anas Barbariae Hepatis et Cordis Extractum. Latin obscures the fact that the product contains Muscovy duck liver and heart, a product that has no efficacy, or reason for efficacy, against influenza. Although called an extract, letting a piece of duck liver and heart liquefy for 40 days and then diluting it in liter after liter of water (200 times) is not what most would consider an extract.

The ‘dose’ of the Oscillococcinum is 200CK which sounds strong, certainly stronger than the 10X, 30X, found in the King Bio Asthma homeopathic product, despite actually being diluted many thousand times more. If the serial dilutions of homeopathic nostrums were in plain English it would help consumers to be more aware of what they were purchasing.

It would be of benefit to the consumer to be informed that at the offered homeopathic dilution, the product should contain none of the original product.

The use of Latin and obscure dosing information runs counter to the current emphasis on health literacy: making all health care information understandable to all Americans, regardless of education. You should not have to know a dead language and college chemistry to understand your medication label.

It would also be of benefit to note on the label that no homeopathic product has ever been demonstrated to be effective for any medical condition.

For example:

Oscillococcinum: Duck heart and liver diluted to

This product as made should contain none of the original substance and no homeopathic product has ever been shown to treat any disease.

Given that there is no Physicians’ Desk Reference (PDR) and package insert equivalent for homeopathy, makes accurate and accessible labeling all the more important for consumers.

That the Homeopathic Pharmacopeia of the United States is behind a very expensive pay wall ($100 a day for a single user) represents an appalling barrier for consumers and health care professionals to understand homeopathic nostrums. It is in the public interest that this information be as freely available as the information in the PDR so that evaluations about the use of homeopathic nostrums can be made with all the available data. Can you imagine if the information in the PDR were equally unavailable? But big homeopathy has good reason to hide its data.

That would be transparent labeling, truth in advertising, and would protect the consumer by offering accurate and easily-understood information about the product. Cigarettes and alcohol have similar labels, clearly spelling out the contents and dangers in the product. Homeopathic nostrums and consumers deserve no less.

Accurate and easily understood labeling, free and easy access to the Homeopathic Pharmacopeia of the United States and the prohibition of OTC sales of homeopathic preparations, would all be important steps in consumer protection and the regulation of nostrums that, while legal in the US, are worthless and dangerous.




Posted by Mark Crislip

Mark Crislip, MD has been a practicing Infectious Disease specialist in Portland, Oregon, since 1990. He is a founder and  the President of the Society for Science-Based Medicine where he blogs under the name sbmsdictator. He has been voted a US News and World Report best US doctor, best ID doctor in Portland Magazine multiple times, has multiple teaching awards and, most importantly,  the ‘Attending Most Likely To Tell It Like It Is’ by the medical residents at his hospital. His growing multi-media empire can be found at edgydoc.com.