The U.S. Food and Drug Administration (FDA) and Health Canada have issued a widespread recall of products manufactured by King Bio. King Bio manufactures hundreds of homeopathic remedies that are marketed to treat countless numbers of conditions in adults, children, and pets. Homeopathy is often misunderstood as a natural remedy, akin to a type of herbalism. The marketing and labeling of these “remedies” encourages this perception, often describing homeopathy as a “gentle” and “natural” system of healing, and putting cryptic terms like “30C” beside long Latin names of what appears to be the active ingredients. However, homeopathic remedies typically don’t contain any active ingredients at all, and the worst that can be said is that homeopathy an expensive placebo that harms primarily by delaying proper treatment. But King Bio’s remedies may be actively harmful. An FDA inspection found an unwanted active ingredient: microbial contaminants such as Burkholderia multivorans which has the potential to cause serious illness.
Water magic 101
Homeopathy is a recurring topic on this blog, and while the regular SBM reader has read this before, it continues to surprise me that few people that purchase homeopathy realize just how ridiculous it is. Homeopathy is based on the idea that “like cures like”, in that a small dose of what causes a symptom can actually cure that symptom. Like-cures-like is simply magical thinking, a pre-scientific belief that was first described in 1890 by anthropologist Sir James George Frazer in the book The Golden Bough:
If we analyse the principles of thought on which magic is based, they will probably be found to resolve themselves into two: first, that like produces like, or that an effect resembles its cause; and, second, that things which have once been in contact with each other continue to act on each other at a distance after the physical contact has been severed. The former principle may be called the Law of Similarity, the latter the Law of Contact or Contagion.
The so-called “Law of Contagion” is still very much alive, and is the basis for pseudoscientific ideas such as “detox” and “eating clean“. It is also the entire basis of homeopathy. Samuel Hahnemann invented the practice of homeopathy, based on the ideas of sympathetic magic, in the early 1800s, with two main principles:
- Like-cures-like: in homeopathy, a substance that is believed to cause a symptom, is diluted to treat that same symptom. Any substance is believed to be a medicine if it’s diluted enough: cancer, boar testicles, crude oil, oxygen, skim milk, even vacuum cleaner dust or moonlight can be a homeopathic remedy. Deciding which substances will cure which symptoms is determined by a process called a “proving” which is equally without any scientific basis. (Here are homeopathic provings for the Berlin Wall remedy and also sunlight reflected off the planet Saturn, to give you an example of the how the remedies are created by homeopaths.)
- Water has a memory: the more you dilute the substance, the more powerful its effect is believed to be. And when I say dilute, I mean dilute. The 30C “potency” is a common dilution used in homeopathy – that’s a dilution of 10-60. You would have to give two billion doses per second, to six billion people, for 4 billion years, to deliver a single molecule of the original, pre-diluted material. Most homeopathic remedies are completely inert, and don’t contain a single molecule of what’s on the label. Whether bottled as a liquid or dripped onto lactose and sold as tablets, they are pure placebo. Except, perhaps, in the case of homeopathic remedies recalled by King Bio.
When Hahnemann invented homeopathy, he described it as a separate and more effective form of medicine compared to “conventional” medical practices. Given homeopathy is an elaborate placebo system, homeopathy probably was safer than medical practice at the time, which was still based around the idea of the four humors. Eventually, germ theory emerged, ideas of humors disappeared, and medicine slowly turned towards a scientific model based on objective observations. Homeopathy, on the other hand, has never progressed or evolved based on evidence, because it was never based on science or evidence to begin with. Its practices today are frozen in the same beliefs from the 1800s. However, the number of products on the market has grown in recent years, owing to a lack of regulatory oversight, no requirement to do clinical trials, and probably most importantly, no active ingredients.
In the United States, homeopathy products are not inspected or approved by the FDA. In December 2017 the FDA proposed a new risk-based approach to regulating this growing practice:
Under the law, homeopathic drug products are subject to the same requirements related to approval, adulteration and misbranding as any other drug product. However, prescription and nonprescription drug products labeled as homeopathic have been manufactured and distributed without FDA approval under the agency’s enforcement policies since 1988.
“In recent years, we’ve seen a large uptick in products labeled as homeopathic that are being marketed for a wide array of diseases and conditions, from the common cold to cancer. In many cases, people may be placing their trust and money in therapies that may bring little to no benefit in combating serious ailments, or worse – that may cause significant and even irreparable harm because the products are poorly manufactured, or contain active ingredients that aren’t adequately tested or disclosed to patients,” said FDA Commissioner Scott Gottlieb, M.D. “Our approach to regulating homeopathic drugs must evolve to reflect the current complexity of the market, by taking a more risk-based approach to enforcement. We respect that some individuals want to use alternative treatments, but the FDA has a responsibility to protect the public from products that may not deliver any benefit and have the potential to cause harm.”
And that’s exactly what’s occurred with King Bio. Multiple products have been recalled as there was concerning evidence of bacterial contamination found.
King Bio’s homeopathy recall
King Bio is a homeopathy manufacturer. That is, they are not a pharmaceutical company that manufacturers drug products under processes that are subject to FDA inspection. “Dr.” King is a chiropractor and naturopath. King Bio has been criticized by the FDA in the past for making medicinal claims about the products it sells, without any evidence its products are effective.
This is a significant recall affecting about 600 products, sold under names like “Dr. King’s: Natural Medicine”, “Aquaflora”, “Natural Pet Pharmaceuticals”, “SafeCareRx”, “Natural Veterinary”, and “Safecare”. Products recalled include homeopathic candida treatments, homeopathic “flu relief”, homeopathic “stress control”, chicken pox “symptom relief”, homeopathic “fever reducers”, homeopathic “attention and learning enhancer”, homeopathic “kids bed wetting”, homeopathic “kids sleep aid”, homeopathic “EMF detox” and on and on and on and on. If you’re wondering how it’s possible that one small company can possibly manufacture so many products, recall that homeopathic remedies, when diluted (and prepared safely) are indistinguishable from each other – and from an equivalent placebo. They contain no medicine and no active ingredients. So there is likely no meaningful difference, from a manufacturing perspective, between “Food Chemical Intolerances” and “Good Mood Enhancer” or even “Indoor Air Pollution Detox”.
The FDA notes the following:
The FDA recently inspected King Bio’s facility and collected product samples. The FDA is currently testing and analyzing product samples collected at the facility. According to the company, several microbial contaminants were found in its products, including Burkholderia Multivorans, which is a strain of bacteria called Burkholderia cepacia complex (BCC) that can cause illness in people with compromised immune systems. Additionally, evidence collected during the FDA’s inspection indicates recurring microbial contamination associated with the water system used to manufacture drug products.
King Bio voluntarily recalled three drug products labeled as homeopathic due to confirmed microbial contamination in July 2018. The company then expanded its voluntary recall to include an additional 32 drug products on August 22, 2018. The FDA contacted King Bio on August 23, 2018, and recommended the company again expand its recall to include all products that use water as an ingredient, including drug products for humans and animals. The company is expanding its recall to drug products made with water marketed for human and animals.
Homeopathy is ineffective
Despite the implausibility of homeopathy, and its ejection from the practice of medicine, it retained some popularity over time, with a resurgence in the past few decades as an “alternative” medical system. Rigorous clinical trials confirm what basic science predicts: homeopathy’s effects are placebo effects. While there are plenty of clinical trials that show homeopathy is associated with positive clinical effects, they are always small, poorly controlled, and often biased. Two of the more recent comprehensive reviews of the evidence are the 2010 Evidence Check from the United Kingdom’s House of Commons Science and Technology Committee and the 2014 Australian National Health and Medical Research Council review, which are worth perusing if you haven’t seen them before.
Bacteria or not, skip the homeopathy
If you’ve never bought it before, homeopathy is not cheap: Its prices are comparable to conventional medicine that actually has active ingredients. Given the lack of efficacy, every dollar spent on homeopathy is a waste of resources, in that it could otherwise be put to more effective use — for plausible treatments, or anything else, for that matter. Regrettably, when it comes to homeopathy, consumers can’t depend on regulators to ensure marketed products are both safe and effective. In the King Bio example, the FDA has only acted because these products are unsafe – not because they are ineffective. Until there’s more effective regulation in place the most effective strategy is to steer clear of any product labelled “homeopathic”.