If you strip away the political controversy, the core story here is rather straightforward. Samuel A. Girod was selling a patent medicine he called “TO-MOR-GONE” with claims that it could cure skin disorders, sinus infections, and cancer. What he was doing was identical to the patent-medicine sellers of the 19th century – putting together some concoction of chemicals and making completely unsubstantiated medical claims. This is the kind of specific behavior that the FDA was created to regulate.

In this case Girod’s patent medicine contained an extract of bloodroot (Sanguinaria canadensis). Bloodroot contains benzylisoquinoline alkaloids, which are toxic and highly caustic substances. It destroys animal cells on contact. There are a number of “alternative” or herbal salves that are similarly highly caustic substances (with bloodroot being a common ingredient) that are sold as treatments for skin cancer and other conditions. The idea is to burn away the cancer.

Another example is black salve. Sometimes it is claimed that such treatments will kill cancer or abnormal cells, but leave healthy cells unaffected. This is untrue and actually quite absurd. These substances are simply caustic – they kill everything. They are similar in effect to pouring acid on your skin. Using these products is likely to cause disfiguring lesions (warning – the images in this link are gruesome), and is also unlikely to completely remove a cancer.

What this shows is how ideologically flexible so-called “alternative” medicine can be. On the one hand proponents rail against the “cut, burn, and poison” approach of standard cancer treatment. This is an unfair characterization of evidence-based anti-cancer treatments, which are targeted as much as they can be, and are only used when they show benefit in excess of risk. Alternative treatments are supposed to be kinder and gentler. But then they also promote as “alternative” a caustic poison that non-specifically burns away tissue leaving behind often horrific scars.

This is justified because the caustic poison is “natural” – an appeal to nature, one of the most deceptively harmful concepts in our culture. The notion of “natural” is used to justify all sorts of false dichotomies, and “greenwash” over a meaningful analysis of mechanism and risks vs benefits. It is a marketing term used, as marketing terms often are, to encourage people to trust their manipulated gut feelings rather than to think reasonably or scientifically about a claim.

Healthcare freedom

Many countries, including the US, sensibly have a system in place for evaluating medical products to protect the public from fraud, waste, or harm. Evaluating medical products is complicated and can even be risky, and it is unrealistic to expect that individuals will be able to parse the dense medical literature to evaluate claims on their own. People tend to rely on their personal anecdotes or word-of-mouth, which are fantastically unreliable when it comes to medical treatments. Plus, once an herbal salve burns a disfiguring hole in your arm or face you cannot be remedied simply by asking for your money back.

The notion that the market can sort out medical products is, in my opinion, naïve and ill-considered. Essentially the choice is between two systems of evaluating medical products. We can do carefully designed and executed clinical trials that are intended to minimize risk and arrive at the most objective and reliable answers possible. Or we can do uncontrolled trials with real-world use, which will produce ambiguous and mostly worthless results and cause a great deal of harm in the process.

In fact most Americans assume that if they go to the pharmacy and buy a health product, that product has been tested and approved, that the claims made are reasonable, and the product is basically safe to use as directed. This is similar to assuming that if you drive over a bridge, the design, construction, and maintenance of that bridge has been inspected and it is not up to you to decide if the bridge is safe or if it’s likely to collapse underneath you. I also think most people would be unsatisfied with the notion that if the bridge collapses you, or your estate, can always sue the engineer for damages.

And yet proponents of worthless, potentially harmful, and scientifically implausible treatments (i.e. “alternative”) often appeal to freedom in order to fend off regulations intended to protect the public from snake oil. The case of “TO-MOR-GONE” is no different. In this case the fact that the harmful product is being sold by a folksy Amish farmer just adds to the optics.

Girod has taken this strategy farther than most. He claims that the federal government has no jurisdiction over him. According to reports:

“I am not a creation of state/government, as such I am not within its jurisdiction,” Girod wrote. He added later: “The proceedings of the ‘United States District Court’ cannot be applied within the jurisdiction of the ‘State of Kentucky.’”

It’s odd that he, on the one hand, says he has no connection to any state, then invokes the sovereignty of the “State of Kentucky” for protection. He may have missed the fact that we fought an entire war over this very question with a very definitive outcome.

Girod was convicted and sentenced to six years in prison. I think that is a reasonable sentence for selling an unapproved caustic substance to the public with instructions to put it on your skin. However, much of that sentence is likely due to Girod’s direct resistance to the federal government. He did not allow FDA agents to inspect his manufacturing process. Also, and likely most damning, he threatened a potential witness and was therefore convicted of tampering with a federal witness.

And yet the alternative medicine community came out to support Girod, buying into the “natural” and “health freedom” narratives that they have been using to sell fraudulent medical products and services.

On close inspection it becomes clear that, at its root, the alternative medicine movement is anti-consumer. Their goal is to erode the regulations that protect the public from bad medicine, so that they will be free to sell products and services that were once considered “health fraud.” It is disheartening, the extent to which they have already been successful.

Posted by Steven Novella

Founder and currently Executive Editor of Science-Based Medicine Steven Novella, MD is an academic clinical neurologist at the Yale University School of Medicine. He is also the president and co-founder of the New England Skeptical Society, the host and producer of the popular weekly science podcast, The Skeptics’ Guide to the Universe, and the author of the NeuroLogicaBlog, a daily blog that covers news and issues in neuroscience, but also general science, scientific skepticism, philosophy of science, critical thinking, and the intersection of science with the media and society. Dr. Novella also contributes every Sunday to The Rogues Gallery, the official blog of the SGU.