No convincing reasons have been advanced either in the comments or the workshop as to why efficacy and safety claims for OTC homeopathic drugs should not be held to the same truth-in-advertising standards as other products claiming health benefits.
In other words, as I understand it, homeopathic products will be held to the same advertising standards as other medical products; basically, if you claim your product provides a medical benefit, you’re going to have to show some evidence.
As I understand it, way back when, the government carved out a big exemption for homeopathy in federal regulations, because of the influence of a senator(?) who was into homeopathy and managed to convince the government that the homeopathic community would police itself.
Bear in mind, the policy change above comes from the FTC, not the FDA. The FDA held hearings last year and is still debating what to do about regulating homeopathy. But it’s also been a thorn in the FTC’s side, because the exeption made advertising standards inconsistent: if a pharmaceutical company has a drug that helps with hay fever, it can’t put out an ad saying so unless they have evidence — that is, in practice, unless they’ve conducted experiments that show that their drug works the way they say. But if you slapped the word “homeopathic” on the label, all of a sudden, a much more lax set of criteria applied. So this is a step in the right direction.
Now, I don’t expect that this will seriously discourage homeopaths. Rather, I expect they’ll just follow the same path as makers of glucosamine and other dietary supplements: they’ll rewrite the labels to give the impression that it works, without actually coming out and saying so.
To see what I mean, take a look through GNC’s Vitamins & Supplements section. The strongest, most concrete claims, like “Improves joint comfort” all seem to have a footnote saying that the FDA hasn’t actually checked to see if that’s true. Unfootnoted statements say things like “Clinical-strength doses of <whatever>”, which doesn’t tell you whether it works or not.
Or just list various health benefits on their own: “Antioxidants • Heart Health • Prostate Health • Mental Sharpness”. Presumably these are intended in the same way as a Bernie Sanders bumper sticker on the car: a statement that Bernie is good, not that he’s actually inside the car.
Yesterday was day two of homeopathy hearings at the FDA. There were some audio and connectivity problems, and again, I was distracted, but I tried to pay some attention.
One or two presenters tried to explain why you can’t perform randomized double-blind clinical trials to demonstrate the efficacy of homeopathic remedies. Apparently it boils down to “homeopathy doesn’t work that way”, though I didn’t catch the specifics. Apparently you can’t test homeopathic remedies on animals because, um… I’m not sure. Also, a homeopath will prescribe a whole array of remedies, tailored to the needs of the individual patient; just like what oncologists do, and somehow that gets in the way of studying homeopathy, but not cancer. And homeopathy often involves evaluating subjective self-reported symptoms, so you can’t study homeopathy clinically, even though doctors study self-reported subjective symptoms like pain all the time. So the upshot of this line of argument was that homeopaths should be exempt from the rules that say you have to demonstrate that your medical treatment actually works.
In fact, one presenter, if I heard him correctly, went so far as to claim that all the other homeopaths have it wrong. This guy had a slide saying that when you dilute a substance, the “Initial substance transits to a new physical condition”. I’ll just leave that authentic frontier gibberish there for you to marvel at.
Another line of argumentation, advanced by several presenters, particularly those on the business end of things, was that homeopathy is big business and growing, and therefore it should not be regulated. I think one person at least tried to make that into a coherent argument by claiming that regulating homeopathy would throttle innovation. You know, kind of like how you never hear from Novartis, Pfizer, or Merck these days because they’ve closed up shop.
Throughout the day, there was a steady drumbeat of “homeopathic remedies are safe”, although usually with an caveat: “properly-prepared homeopathic remedies are safe”. Properly-prepared homoepathic remedies are just distilled water, which I agree is safe. But homeopathy is currently unregulated, or nearly so, and thus no one is checking to make sure there’s nothing bad in your expensive distilled water.
In fact, as we heard in the previous day’s testimony, a lot of times manufacturers will combine things, e.g., take a regular zinc supplement and sprinkle homepathic water on it, and sell it as a hybrid or stick a “homeopathic” sticker on the box. People who have heard that homeopathy, whether it works or not, is at least safe, can and do take more than the recommended dose, and ingest unhealthy amounts of zinc. That by itself should be an argument for regulation and proper labeling.
But perhaps the most depressing aspect of the hearings were the practicing doctors testifying in favor of homeopathy, using the same arguments as everyone else: “I’ve seen it work. And it’s popular. Plus, it’s safe”. These are smart, well-educated people, who every day prescribe medications that have gone through rigorous controls to eliminate things like personal bias and proof by anecdote, committing those very errors.
At any rate, the current phase of the circus is over. With any luck, the FDA will start cracking down on this woo. I’d call it snake oil, but statistically speaking, there’s probably not a single molecule of the original oil left.
Today and tomorrow, the FDA is holding hearings to see about updating its regulations for homeopathy. Or, as NPR puts it, FDA Ponders Putting Homeopathy To A Tougher Test. Here, “a tougher test” means applying the same rules to homeopathy as to every other proposed medical treatment: see whether it works.
So to that end, they’re holding two days of hearings. I was able to stream part of the proceedings, and even hear some of it (though I was busy, and thus missed a lot).
But first, it might be good to review what homeopathy is. homeopathy.com explains:
Homeopathy’s basic premise is called the “principle of similars,” and it refers to recurrent observation and experience that a medicinal substance will elicit a healing response for the specific syndrome of symptoms (or suffering) that it has been proven to cause when given in overdose to a healthy person.
Most homeopathic medicines are made by diluting a medicinal substance in a double-distilled water. It should be noted that physicists who study the properties of water commonly acknowledge that water has many mysterious and amazing properties. […]
Each substance is diluted, most commonly, 1 part of the original medicinal agent to 9 or 99 parts double-distilled water. The mixture is then vigorously stirred or shaken. The solution is then diluted again 1:9 or 1:99 and vigorously shaken. This process of consecutive diluting and shaking or stirring is repeated 3, 6, 12, 30, 200, 1,000, or even 1,000,000 times. Simply “diluting” the medicines without vigorously shaking them doesn’t activate the medicinal effects.
In other words, you find a substance that produces a given symptom in healthy people; you dilute that substance in water until there’s none of it left, and you give your bottle of water to a person who suffers from symptoms like what you found earlier.
Or, as Mitchell and Webb described it, “trace solution of deadly nightshade or a statistically negligible quantity of arsenic”:
So the question before the FDA is to determine whether homeopathic substances, which are touted as remedies for everything from gout to nonspecific unease, should be subject to the same regulations as, say, Tamiflu or Ibuprofen or Viagra. The sorts of regulations where if you say that your product is good against X, the FDA comes along and says, “proof or STFU”.
Apparently Michael de Dora of the Center for Inquirytestified early on, but I missed it. His testimony can be summed up as “Science has known for a long time that homeopathy doesn’t work. The US government knows this. Hell, the FDA has said as much. This year. Let’s not support pseudoscientific quackery.”
The first speaker I caught was giving an overview of studies on homeopathy. At first, he couldn’t do better than saying that there are studies that show that it works, and others that don’t. But he was able to drag in other factors, like the file drawer effect (that negative results tend not to get published) and the Hawthorne effect (people who know they’re being watched behave differently) to cloud the issue enough to be able to say that the science isn’t settled. Sadly, he was one of the most reasonable speakers of the day.
Several ideas came up in different people’s testimony before lunch:
That homeopathy has organizations of practicing professionals, therefore it works.
That homeopathy has a standard reference book, therefore it works.
That there’s quality control (i.e., people check that your bottle of 99.99999% water really does contain 99.99999% water), therefore it works.
That members of the general public don’t really know a lot about homeopathy (this might become significant, later).
That I just know that it works, therefore it works. (Who needs double-blind clinical trials when you have feelz?)
That homeopathy is popular, therefore it works.
One speaker made the argument that France has an excellent public health-care system, and that homeopathy is popular in France (therefore, presumably, homeopathy works). He also mentioned, or implied, that it had been approved by Swiss healthcare regulatory bodies. During the Q&A period, he was asked how French and Swiss researchers had evaluated the effectiveness of homeopathy, and in response he went off on a tirade against US regulators. I believe that’s called evading the question.
During the afernoon session, several more ideas came up several times:
Homeopathy works in conjunction with other treatment (I had a headache, so I took an aspirin and a homeopathic remedy; my headache went away; therefore, homeopathy works).
Homeopathy is popular, therefore there’s no need for stricter regulation. (I wonder if that argument also applies to heroin.)
Homeopathy is big business, therefore there’s no need for stricter regulation.
Homeopathic remedies are already marked “homeopathic”. What more do you people need? Informed customers (which morning testimony said many people aren’t) can make an informed choice.
One shining light was Luana Colloca of the University of Maryland, Baltimore. She actually cited studies and showed empirical results, and even graphs with error bars, mirabile dictu! She gave an overview of the power of the placebo effect, though I’m not sure what her point was. Was it that hey, placebos lessen people’s pain, therefore let’s let people have their sugar pills?
But beyond that, the theme seemed to be that things are fine the way they are; informed consumers can caveat emptor their way through drug store aisles. And besides, it’s popular, and big business. So why should Big Alt-Med be regulated the same way as Big Pharma? Unfair!
What I found notably missing from the proceedings, and which I would gladly have welcomed, was anything along the lines of “Yes, homeopathy is effective against X, Y, and Z. And we have the double-blind, statistically-significant clinical trials to prove it.” I suppose that was too much to expect. Ah, well. I still has feelz. And a tall drink.