We have had to endure a great deal of interference from government in the conduct of institutions that should be governed by science and evidence. I’m sorry to report – here is one more. Senators Mike Lee (R-UT) and Tommy Tuberville (R- AL) have recently introduced a bill that would limit the FDA’s ability to regulate the blatant pseudoscience of homeopathy. This is how they frame it: “The Homeopathic Drug Product Safety, Quality, and Transparency Act will provide a pathway for homeopathic medicinal products to be lawfully marketed by the Food and Drug Administration without needlessly banning safe products that simply do not fit into the same legal categories as traditional pharmaceuticals.”
They are promoting this bit of malfeasance with the usual tropes:
“Americans have a right to manage their own health and choose treatments that are right for them, including homeopathic methods,” said Senator Mike Lee. “The current federal regulatory framework is designed around traditional pharmaceuticals, but it is ill-equipped to review the safety and effectiveness of homeopathic products.
“I’ve long been an advocate for homeopathic medicine,” said Senator Tommy Tuberville. “The reality is that too many Americans today are hooked on pharmaceuticals when they could be using homeopathic remedies, which are often cheaper and can yield miraculous results.”
There is a lot to unpack in these statements, but let’s start with a quick review of what homeopathy is. It was invented in the late 18th century by German physician Samuel Hahnemann, based on prescientific notions. First, it uses substances which allegedly cause specific symptoms to treat those same symptoms. This is nothing but sympathetic magic (it is not based on any principles similar to vaccines, for example). These substances are often fanciful, and some even don’t exist. Oscilococcinum, still a popular homeopathic product, is nothing but artifactual air bubbles on a slide, mistaken for an organism by an ignorant and confused homeopath.
The silliness of the starting ingredients are also irrelevant – because whatever they are they are typically diluted out of existence (so homeopathy is magic squared). Homeopaths sometimes claim the “essence” of the substance remains, but there is no mechanism for this, nor for it to be stored in sugar pills or get absorbed into the body or have any effect on the body. In order for homeopathy to work one would have to believe in a chain of impossible things (even The White Queen would find this challenging).
Despite that, homeopathy has been clinically studied – and unsurprisingly, it doesn’t work. To put it more technically, there is insufficient evidence to reject the null hypothesis that homeopathic products have no specific efficacy or any effect beyond placebo for any indication. Multiple independent systematic reviews have come to this basic conclusion. Magic, it turns out, isn’t real.
Selling a product to the public that demonstrably does not work with claims that it does work is, quite simply, fraud. So why is this allowed at all? Partly because of a US Senator who was a homeopath, Royal S. Copeland (D-NY), who is responsible for creating the current framework in which the FDA regulates homeopathic products. Essentially homeopathy is in its own category, and does not require evidence for safety or efficacy. The FDA decided that homeopathy was too small a market to waste their limited resources on so they just accepted the homeopathic pharmacopoeia as a list of approved products – no evidence required.
However, in 2019 the FDA reviewed its regulation of homeopathy because of the growing industry, and they did strengthen their regulations (although not nearly enough). Mainly they required greater scrutiny of manufacturing for safety and quality concerns, while still ignoring the complete lack of any effectiveness. Meanwhile the FTC changed its regulations requiring more transparency in labeling – again, good but not far enough.
Now it seem that Tuberville and Lee are not happy with the FDA partly doing its job, so they want to stop them. Mike Lee is from Utah, which is the epicenter of the alternative health product industry in the US, so he is likely just serving this industry in his state (as Orrin Hatch did before him). He has been consistently anti-regulation of this industry, with the usually dubious justifications.
Saying that consumers have a right to make their own choices is grossly misleading. It’s like saying they should be able to drive over whatever bridge they want, or consume tainted meat, employ incompetent doctors and car mechanics, or endure unsafe work conditions. It’s nearly impossible for individual people to determine if a medicine is safe and effective from their own anecdotal use. Safety is often a matter of statistics from systematic reviews of many cases, as is efficacy. Placebo and non-specific effects also make efficacy extremely hard to accurately perceive. The existence of the homeopathic industry itself is hard proof of this.
Most people also do not even know what homeopathy is. Further most people falsely assume that if the government approves something, it must be legitimate. Over my career I have had countless conversations with both the public and fellow practitioners, and virtually no one who is not already steeped in skepticism or science based medicine have any idea what homeopathy is. Many are disbelieving when I explain it to them, believing that it can’t possibly be that nonsensical (until they look into it themselves). Given this profound lack of information, it’s hard to argue for consumer choice.
The senators are also borrowing the propaganda from the CAM industry, that scientific methods designed for drugs don’t work for homeopathy or other alternative products. This is also nonsense. Evidence is evidence – either a product is safe or it isn’t, either it works or it doesn’t. Safe and consistent manufacturing processes are also agnostic toward the type of product. This is just all pro-industry anti-consumer regulation sold with the same laughable justifications that we typically get.
So we appear to have an industry shill and a true believer trying to weaken the FDA’s ability to protect the public from clearly fraudulent and worthless products. Further, MAHA sycophants are lining up behind them.
If you live in the US, you might want to write your senator and explain that you want the FDA to actually protect US consumers from blatant health product fraud.
