Mozi-Q – “Insect repellent you eat”. But does it work?

Today’s post is a guest contribution from a Canadian pharmacist who is writing under the pseudonym Sara Russell:

Every morning I open up Facebook and expect to see the usual sharing of my friends’ latest adventures in pseudoscience, but it wasn’t until this morning that I felt compelled to write about something.  A friend had posted this video asking for feedback.

When homeopathy is approved as an insect repellent, there’s a serious regulatory problem

Given their visibility in the pharmacy, a recurring topic of this blog are the category of products deemed “natural health products”. My philosophy towards their uses has changed over the years, and what was an “evidence-based” approach is now firmly a “science-based” approach. A central principle to science-based medicine or pharmacy is that all health interventions and treatments should be evaluated based on a single, scientific standard. One of the biggest successes of the alternative medicine industry, worldwide, has been the embedding of different regulatory standards for the evaluation and approval of so-called “non-drug” products such as supplements, herbal products, and non-scientific treatment systems like homeopathy or traditional Chinese medicine (TCM). The implications cannot be overstated: this different and lower standard is now so firmly entrenched in most health systems that few seem to question its rationale, or consider the consequences. As a practicing pharmacist I spent the first decade of my career working within this regulatory framework without ever stepping back to question why we regulate some products differently.  Comparing two countries illustrates my point:

Homeopathy and Consumer Protection

Editor’s Note: It’s World Homeopathy Awareness Week.

Today’s guest post is from Dr. Chris MacDonald, PhD. Dr. MacDonald is Associate Professor, Department of Philosophy, Saint Mary’s University, and a Nonresident Senior Fellow at Duke University’s Kenan Institute for Ethics. Dr. MacDonald blogs at the Business Ethics Blog.

What should we think about homeopathy, from the point of view of Business Ethics? We can begin by asking the same questions about homeopathy as we would ask about any other product. Those questions fall under two main headings:

1. Is it generally ethically OK to sell this product? Is it a product that should be on the market at all?
2. If it’s generally ok to sell this product, what are the obligations of companies selling them? Are there any ethical limits on how or to whom they are marketed?

In a free society, there’s a general presumption in favour of free commerce. If Party A has a product and says to Party B, “Hey, you might like this,” and if Party B says, “Hey, I think I’d like some of that, here’s some money!” then they should generally be free to make the transaction. But there are limits. Some things cannot ethically be bought or sold (children or votes, for example). Other things can be sold, but only under special circumstances (cigarettes and alcohol, for example). And more generally, there is a very broad requirement that all transactions must be carried out without force, fraud, or deception.

Now, discussions over alternative therapies like homeopathy tend to be combative, rather than constructive, particularly on the Internet. That’s unfortunate, because a lot is at stake. Finding ways to have a constructive discussion is essential, but few make that effort. But there is common ground in the debate, and we should make good use of it. Both sides of the debate agree, for example — indeed they ethically have to agree — on the importance of consumer protection, though they may disagree on the right way of achieving it. Health is complex, and important, and the average consumer typically needs to be able to turn to experts to get good advice. There are plenty of unscrupulous individuals and companies out there willing to try to make a fast buck by preying on the gullible or the uninformed. Anyone who truly cares about health has to recognize that that’s a serious problem.

So, let’s look at homeopathy through the lens of consumer protection. Most generally, consumer protection means, first, making sure that products are safe (or “safe enough”, since almost all products carry at least some risk), and, secondly, making sure that products do what the manufacturer or seller says they’ll do.

Although I happen believe that homeopathy (like most other alternative therapies) does not in fact work, I want to have a constructive discussion about consumer protection with those who think it does. So I’m going to assume, for the sake of argument, two things that many skeptics are likely to deny.

1. First, I’m going to assume that homeopaths (and supporters) genuinely believe in the power of homeopathy. That is, I’m going to assume that most homeopaths are not outright frauds. (Actually, that’s not just for the sake of argument. I strongly believe that to be a justified assumption. I strongly suspect that the vast majority of homeopaths and homeopathic pharmacies are 100% well-intentioned, and seek only to promote the health of their patients and customers.)
2. Secondly, I’m even going to assume — again for the sake of constructive argument — that homeopathy works. I’ll assume that the anecdotes of homeopaths and their patients confirms the positive effects that Randomized Controlled Trials have thus far been unable to detect.

Next, given these assumptions, I’m going to pose two questions for homeopaths to answer, questions that I would likewise pose to any other kind of reputable business, especially any other reputable business in the field of health.

1. How do we detect phoney homeopathic preparations? In order to protect consumers, we need to be able to detect fake remedies — fake versions (sold by counterfeiters) that are really just inert look-alike copies of genuine remedies. In an age of international trade and Internet-based pharmacies, phoney pills are a big problem. So, is there any way to test a homeopathic preparation to verify that it is genuine? If I buy homeopathic tablets, is there any test that can be done to see if they’re real or counterfeit? If authorities suspect a criminal organization of selling fake homeopathic tablets, how can they tell the difference between the criminal organization’s tablets and those manufactured by an honest homeopathic pharmacy?
2. What advice would you give a potential patient/customer who is trying to choose among various alternative therapies? How should a potential customer/patient choose between homeopathy, Therapeutic Touch, acupuncture, Angel Therapy, and so on? In other words, how can consumers know that they’re about to buy something good, rather than something bogus? “Trust me” won’t do as an answer. Trust, in itself, is neither a good nor a bad thing; what we value is justified trust. What is it that justifies consumers in trusting you, rather than someone else? “Try it” also isn’t a good answer. When health is on the line, we shouldn’t have to experiment on ourselves. We should have some assurance ahead of time. Consumers deserve that. One alternative, of course, is to deny that this is an important question at all, by claiming that literally all alternative therapies work. But that would make little sense. There surely are fraudsters out there, offering stuff they know can’t work. And even ignoring outright fraud, the homeopathic philosophy claims to have identified the true nature of disease; other philosophies, it seems then, must have it wrong. Which ones? Consumers deserve your input on this important issue.

These are questions I expect any reputable business to be able to answer. They are also questions to which I have not yet heard homeopaths give good answers. (In fact, I asked a version of the 2nd question on my blog, with depressing results.) I’m honestly interested to hear any an answer.

In the end, what I’m really looking for here are reasonably generalizable standards of consumer protection across various categories of health products. What standard of evidence and safety should be applied to products offered for sale, quite generally? If homeopathic preparations are not expected to stand up to the rigours of Randomized Controlled Trials, why, in all fairness, should the products of the major pharmaceutical companies be forced to meet that standard? Surely Merck and GlaxoSmithKline would love to avoid having to jump through those hoops. Surely Big Pharma would love to be able to give vague answers to my questions above. But we don’t let them. And we’re right not to let them. The question is, can the Homeopathic industry demonstrate its commitment to ethics by giving clear answers, too?

Do the Natural Health Products Regulations Benefit Canadians?

How much confidence do you have in natural health products?

Shortly after I started practicing as a pharmacist, I began giving two disclaimers whenever speaking with patients purchasing herbal products:

Compared to drugs, there is little regulation of herbal products. Variation could exist between what it says on the label and what it actually contains.

And if they have medical conditions or are taking prescription drugs, I would add,

Compared to prescription and over-the-counter drugs, the information we have on these products limited. They could have the potential to interact with other medications and medical conditions that we are not aware of. They should be used with caution.

I would give a similar disclaimer for other types of supplements and “alternative” products.

Why a disclaimer, with every patient, every time? Because the Canadian regulatory framework does not give me the confidence that natural health products available for sale in Canada are either safe or effective. Most importantly, I could not even tell patients with confidence that what was on the label was actually in the bottle.

Change is Coming. Slowly.

Until several years ago, Canadian natural health products fell into a regulatory grey zone.  Products were treated either as drugs, or as foods. Consultation began in the late 1990’s on a new framework to provide appropriate levels of  regulation and oversight to these products. In 2004, the Natural Health Product Regulations (NHPR), under Canada’s Food and Drugs Act, became a reality.  Rather than fully regulating these products as drugs, or leaving them virtually unregulated (as is done in the United States), the NHPR were a regulatory compromise: Implementing manufacturing quality and safety standards, while significantly relaxing the standards for product efficacy claims.  If randomized, double-blind, placebo-controlled trials are not conducted, (the standard for drugs), manufacturers can make claims based on “traditional uses” and other sources that are essentially anecdotal in nature. The NHP regulations include products such as nutritional supplements, probiotics, traditional Chinese medicine, vitamins, herbal products, and homeopathy.

One of the most important elements of the NHP regulations was the implementation of pre-marketing registration requirements. Only products reviewed and deemed to meet minimal standards of product quality, safety, and the (relaxed) standard for efficacy claims would be permitted to be sold as of 2010. Manufacturers were given six years to meet these requirements.

I was all set to update my disclaimer. Until now.

Should We Maintain an Open Mind about Homeopathy?

No.

It is considered unethical for modern medical practitioners to sink to this kind of deception that denies the patient his or her autonomy. Secondly, by opening the door to irrational medicine alongside evidence-based medicine, we are poisoning the minds of the public. Finally, if we don’t put a brake on the increasing self-confidence of the homeopathic establishment, they will cease to limit their attention to self-limiting or nonspecific maladies.

More, from Michael Baum and Edzard Ernst, writing in this month’s American Journal of Medicine, here.

 

The Physics of Homeopathy – Finally Explained!

This has to be seen to be believed. It’s the physics of homeopathy – as explained by a an optometrist who dabbles in homeopathy.  Watch it – but I take no responsibility for the brain cells that will rupture upon viewing.

We discovered a few days ago that even the light reflecting off Saturn can made into a remedy.  When groups lilke naturopaths claim that homeopathy is science, what does this say about their ability to provide reality-based health care? And why do  pharmacists continue to enable this antiquated practice by selling homeopathic products in pharmacies?

Go read the Science-Based Medicine post for a dissection of the “science” in this presentation.

The Alternative that Isn’t: Bioidentical Hormones

The interest in bioidentical hormone therapy (BHT) has seemingly exploded of late, due in part to celebrity books and daytime television discussion. Suzanne Somers, author of multiple books on BHT, recently made her case for BHT on Oprah. According to Somers, BHT is a veritable “juice of life“; appropriate for women from their twenties right up to menopause and beyond. This article will look at the safety and effectiveness of BHT, and the responsibility of pharmacists and the pharmacy profession in its provision.