Tag FDA

FDA Homeopathy Circus, Day 2

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.

FDA Homeopathy Circus, Day 1

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).

If you want to follow along tomorrow, it’ll be at https://collaboration.fda.gov/hprapril2015.

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”:

[youtube http://www.youtube.com/watch?v=HMGIbOGu8q0&w=560&h=315]

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 Inquiry testified 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.

I’d Rather Have a Long List of Scary Warnings than Nothing at All

I recently participated in a coversation—or maybe I’m conflating two or more conversations, but no matter—in which my interlocutor said that she prefers alt-med natural remedies because mainstream drugs all have a long list of scary potential side effects.

But when I asked whether alt-med drugs actually lower cholesterol or help prevent heart attacks or whatever they claim to do, she said that people who sell alternative medicines tend to avoid making medical claims. They’ll say the product “enhances well-being” or some such, but not “this product helps regulate LDL”.

Because what happens is this: if you make a specific claim about physiological effects or the like, that’s a medical claim, and the FDA expects you to back it up. So Pfizer comes along and says, “this new drug, XYZ, improves blood-clotting.” The FDA says, “Oh, yeah? Show me.” And so Pfizer performs studies, or cites independent studies, that show that yes, as a matter of fact, patients who receive XYZ tend to clot better than patients who don’t, even after taking into account other possible explanations, like luck or the placebo effect. And the FDA says “All right, you’ve made your case. You can claim that XYZ improves blood-clotting in your advertisements.” At least, that’s how we want it to go; how we hope that it goes.

Unfortunately, the world is complicated, and it’s never as simple as “take this drug and you’ll get better.” Different people have different bodies and react to things differently—for instance, I have a friend who doesn’t drink caffeine because it puts him to sleep. So at best you’ll have “take this drug, and it’ll most likely help, but it might not do anything.” More often, you get a drug that does what it’s intended to do in the majority of cases, but also has a list of possible, hopefully rare, side effects. But the more participants in the study (which is good), the greater the chance that one of them will have a heart attack or something that can be plausibly be attributed to the drug being studied. So the Scary List O’ Adverse Effects grows.

So yeah, traditional herbal remedies that don’t have words like “vomiting” or “stroke” on the label look appealing by comparison. But that’s only because the people selling the herbs aren’t required to test them, or to publish the negative results. If someone out there did make a specific claim, like “echinacea helps relieve flu symptoms”, and the FDA said “Oh, yeah? Show me”, and they showed ’em, and ran tests and studies and such, there would almost certainly be some adverse side effects to report. If you’re not seeing any, then either someone’s hiding them, or else no one’s looked for them.

In the real world, everything has problems. Saying you prefer alternative remedies to conventional medicine because it doesn’t have a scary list of adverse effects is like getting your financial advice from a psychic instead of an investment banker because instead of scary disclaimers about lawsuits and patents and the possibility of losing all your money, she just has the friendly statement “For entertainment purposes only.”