Homeopathic teething pills: Still poisonous

The Pediatric Insider

© 2016 Roy Benaroch, MD

In 2010, I wrote about the FDA’s recall of Hyland’s Teething Tablets. It turned out that the tiny little pills, sold to allegedly help babies with teething symptoms, had measurable and potentially toxic amounts of a poisonous plant extract, belladonna. See, they were supposed to not actually have any of that, because homeopathic products aren’t supposed to have any of anything.

One principle of homeopathy works like this: by ultra-super diluting a poison, you get a cure for the poison, or at least relief of the symptoms that the poison would have caused if you ingested it. Which, of course, you shouldn’t do (ingesting the actual poison is discouraged, until it’s ultra-super diluted and isn’t there anymore. That’s what you’re paying for.) Those Hyland’s Tablets turned out to contain the poison that wasn’t supposed to be in there. Oops.

By the way, it’s called “belladonna” from the Italian roots for “beautiful woman”. Belladonna comes from the nightshade plant, and this “natural” chemical will make your pupils dilate (that’s the beautiful part.) It can also cause excessive sleepiness, muscle weakness, difficulty breathing, agitation, and seizures. Those parts are less beautiful.

Last week, on September 30, the FDA updated their 2010 release, warning consumers against using any homeopathic teething tablets or gels. This includes not just Hyland’s products, but those sold at CVS and other retail and online stores.

The bottom line: if they’re manufactured correctly, homeopathic products don’t contain any active ingredients at all. There is nothing in there that could possibly help with teething or any other condition. Oh, sure, there may be other things added to homeopathic products to make you drunk, but that’s not the point. Homeopathic products should be as safe as drinking a little water or swallowing a tiny little sugar pill—because that’s exactly what they’re supposed to be, a little vial of water or a tiny little placebo pill.

That’s if they’re made the way they’re supposed to be made. But homeopathic products, like all of the other alt-med goodies sold next to the real medications, aren’t regulated. There’s no guarantee of purity, and no guarantee that what’s on the label is on the bottle. You’re paying for what you hope is a bottle of literally nothing, but you might accidentally get something that can hurt you.

Funny world, isn’t it? Can you imagine someone complaining to the manufacturer that their placebo was contaminated with a biologically active substance that might actually have an effect on their body? Hey, I paid good money for absolutely nothing, and that’s exactly what I wanted!

Anyway: if your baby seems to be having teething symptoms, try hugs and love or a dose or two of acetaminophen. If that doesn’t help, go see your doctor (it may not be teething at all—those little babies can’t talk yet, and it’s hard to know exactly what’s on their minds. Maybe they got a glimpse of that presidential debate, and they’re understandably worried about the future.) “Homeopathic Teething Tablets” certainly aren’t going to help, and might just make your baby sick.

New therapies aren’t necessarily better

The Pediatric Insider

© 2013 Roy Benaroch, MD

The thing about science: it’s not a body of knowledge, or a list of facts. It’s a method. It’s looking at natural things, explaining them, and testing ideas to see if they’re right. More experiments (and better experiments) on more ideas leads to improved understanding and better ways to predict and influence what happens.

But science doesn’t go in a straight line. Not every study is valid, and not every idea is right. Sometimes it takes years (or centuries!) to figure things out. The path is winding and it is difficult to see what’s around the next corner. Still, for matters related to medicine, I think science is the best way to lead us to better health.

Case in point: good science shows us that the way we’re doing things isn’t always the best way. A recent review from the Mayo Clinic looked at ten years of scientific articles, and found that current practices were about as likely to be wrong as correct. Of 363 studies of interventions that were considered “standard of care,” about 40% affirmed that the care good, and about 40% showed that current practice should be changed (the remaining 20% didn’t reach a firm conclusion either way.)

Some examples of studies that contradicted current advice: controlling exposures to mites with impermeable bed covers was found to be of no benefit to asthma sufferers; and pre-implantation genetic studies during in-vitro fertilization actually reduced the rates of pregnancy and live births.

So how should doctors and patients look critically at medical decisions? We can’t just cower in the corner and not make up our minds, waiting for the best possible studies.

Look at the totality of the evidence. The best medical practices are backed up my multiple studies done from multiple points of view. For instance, current vaccine schedules are backed up by hundreds of studies of basic science, immunology, clinical outcomes, and studies of adverse events; these studies have been done in dozens of countries around the globe by thousands of researchers, backed by government, industry, and academic support. The evidence here is a huge mountain that is unlikely to be wrong. Does that mean there isn’t more to learn? Of course not. But vaccine schedules aren’t just a current fad or bandwagon to jump on—there is solid, ever-increasing evidence here that should make people confident.

Be wary of new things. New treatments are hip and cool and heavily marketed, and have that “new car smell” cache. But they’re also more likely to lack multiple studies and solid foundation of experience.

Be humble. Doctors and patients like to be right. Once we’ve decided on a course of action, it is difficult for us to admit we’re wrong and change course. Doing something because we’ve always done it is not good science. Keeping one’s mind open is.

But remember: too much of an open mind means that your brain may fall out. An open mind is good; but there can be too much of a good thing. Look at the world of alternative medicine—have you ever seen any alt-med proponent criticize anything, or proclaim any skepticism of any treatment? To make good decisions we have to be rational, and, yes, judgmental. Things that have no basis in any rational understanding of science, and lack any clinical evidence of any benefit whatsoever (homeopathy), need to be discarded. While other things that do have some rationale and evidence for effectiveness ought to be further investigated and brought into the realm of every-day, real medicine. Doctors and alt-med proponents need to be willing to say, yes, science shows that what we’re doing is wrong.

Do doctors and scientists have all the answers? Of course not. But it’s exhilarating to keep looking.

The poisonous homeopathic pill

The Pediatric Insider

© 2010 Roy Benaroch, MD

The FDA has announced a recall of Hyland’s Teething Tablets, because some lots contain poisonous amounts of belladonna. What was a potentially deadly extract from the nightshade plant doing in the tablets it the first place? Well, it was supposed to be there—but not really, not in the sense of any actual molecules of belladonna actually being in the tablets. No, no. Just kind of the “energy” of the belladonna, the unmeasurable-magical-it’s-there-but-it’s-not part, definitely not the kill-you-dead part. Got it? No?

Hyland’s Teething Tablets are marketed as a “homeopathic” product. From talking with parents, there seems to be a misconception that homeopathy is a kind of natural, herbal medicine that’s been around since ancient times. Nothing could be farther from the truth. Homeopathy is about as super-natural as the tooth fairy, and was invented (that is, “made up”) by a retired physician, writer, and translator, Samuel Hahnemann, around 1800.

I don’t blame Hahnemann. Put yourself in his shoes: “medicine”, as practiced at that time, was still largely based on Galen’s ideas of the four humors. Purging and bleeding being were the main therapeutic options. What Hahnemann realized was that Galen’s approach  was completely wrong. It was killing more people than it helped. What Hahnmann was looking for was a complete departure from the medical philosophy of the day, and what he invented was homeopathy.

The central foundation of his new “medicine” was the concept that “like cures like”, sometimes called “the law of similars.” He and his students would take a bit of an herb or bark or other substance, and see what kind of symptoms it seemed to cause. For instance, just a little bit of nightshade would cause (among many other symptoms) a belly ache. So Hahnemann figured that if the belladonna were diluted, and diluted again, and maybe diluted again a zillion times, the resulting solution would then cure belly aches.

(Not just diluted. The solutions had to be shaken and stirred in a specific way, called “succession.” This released the “vital energy” of the substance, and involved specific sorts of tubes and things to strike them with a certain number of times. I suppose a genuine homeopathic factory would look like it was designed by Willy Wonka.)

“A zillion times” was kind of an unfair term—I don’t know what a zillion is, but Hahnemann’s idea was that the more diluted the substance was, the stronger the cure became. His dilutions went far, far beyond the zillions, often using products diluted to 10^-60 as a cure. Ten to the minus 60, that’s a fraction that looks like 1/1000… (ßput 57 more zeroes there.) That’s not “strong” enough for you? From wikipedia.com 10/30/2010, “Homeopathy”:

A popular homeopathic treatment for the flu is a 200C dilution of duck liver, marketed under the name Oscillococcinum. As there are only about 10⁸⁰ atoms in the entire observable universe, a dilution of one molecule in the observable universe would be about 40C. Oscillococcinum would thus require 10³²⁰ more universes to simply have one molecule in the final substance.^[74]

Homeopathy is entirely supernatural, relying on concepts of power and dilution and “vital energy” that have no basis whatsoever in what we understand of the natural world. Still, it did have one important advantage: in the 1800s, it probably killed far fewer patients than what a lot of other doctors were doing. No purges, no bleeding—just a solution so fabulously diluted that really, you’re just drinking a little water, or taking a little pill of sugar. Harmless fun.

But apparently the makers of Hyland’s Teething Tablets forgot about the “homeopathic” part, and started making tablets out of genuine, measurable, and poisonous amounts of belladonna. Babies have been developing symptoms of belladonna toxicity, and measured amounts of poison in the pills have varied considerably. Since they’re “homepathic” (that is, they ought to contain essentially nothing), products like these do not have childproof packaging, and cases of “overdose” of a genuinely toxic amount of belladonna have apparently occurred.

The FDA has no authority to require testing homeopathic products for safety or effectiveness; they were (and new ones continue to be) essentially “grandfathered” in. Only when harm has already occurred (as in the case with these Hyland’s products) can the FDA step in and test the products to see if they contain poison.

If you have some of these tablets in your home, throw them out. In the future, if you’d like to save some money, I suggest you obtain your homeopathic remedies in an easy, safe, and economical way: just fill a vial with tap water. You can bet that somewhere, someone flushed down the toilet some kind of something that would have made your child sick on some way. By now, that substance has been diluted through all of the lakes and tanks and streams and aquifers in your water system, so it’s released all of Hahnemann’s vital curing properties. That tap water, if Hahnemann was right, ought to cure everything.

If you want to make it stronger, just dilute it with more tap water.

News: Homeopathy and paying for prescriptions

The Pediatric Insider

© 2010 Roy Benaroch, MD

Still catching up from family mishegos, so here’s another short post…. but hey, you get what you pay for, right? Well, maybe not, as these stories illustrate:

Homeopathy, at its core, is based on a silly superstition– a “science” that was made up in the 1800s and doesn’t make any sense at all. To believe in the ability of ultra-super-dilution to increase the effectiveness of a “medicine” flies in the face of everything we know about chemistry and biology. Should your tax dollars pay for this? In the UK, the answer is “no.” In the USA? Stay tuned.

Speaking of people paying for things: the recent health care legislation calls for huge cuts in payments for medical services, including doctor fees and hospital fees. In many places, state-mandated payments for prescription drugs already don’t cover the costs of these medicines to the pharmacy. Should a drug store lose money on every transaction? Chains in California are starting to say “no.” Watch for more of these stories as shoes continue to drop.

Unrelated, but I’ve always had a soft spot for Blossom Dearie: Anyone know anyone from Rhode Island?

Beware “alternative” medicine

I don’t like the phrase “alternative medicine.”

Medicine, as I see it, ought to mean “something that treats or prevents disease.” It should encompass all modalities and methods that can be shown with reasonable certainty to be effective. Whether it’s a drug developed through the research of a pharmaceutical company, a device invented in someone’s garage, an herb that’s been used for thousands of years, or a physical manipulation technique, all medical treatments should be held to the same standard: good, reproducible, and reliable scientific study should show that the method works. Research should also be used to determine what side effects and risks are likely from the treatment, so doctors and patients can judge the risks versus the benefits to determine if using the method is a good idea.

If the treatment meets this criteria—that is, it can be shown to be effective, and its risks are justified by its benefits—then it should be called, simply, “medicine.” It shouldn’t matter whether it’s from the realm of what some people think of as “traditional medicine” or from the realm of “alternative medicine.” If it works, it’s medicine. If it’s not known whether it works because good studies haven’t been done, a good term for it is “unproven medicine.” If good studies have shown that the treatment is ineffective, the best term I can think of would be “quackery.”

The best, most reliable evidence to prove that a treatment is effective is from a well-designed, randomized clinical trial. One good example of such a study is from 2007, when researchers tried to see if honey was an effective treatment for cough. They enrolled a group of about 100 children with ordinary coughs into the study, and with the parent’s permission randomized the kids into one of three groups. Each group got one of three syringes filled with a potential cough treatment. One contained honey, one contained a standard cough medicine, and one was actually empty (no treatment). The honey was thickened and flavored so it tasted like cough medicine, so the parents and kids couldn’t tell which one they’ve tried. The next day, researchers called the families and asked if the cough had improved.

Why all of the deception with the secret treatments? That’s an essential step. Almost all health conditions will improve on their own, without treatment. Just because a patient took something and got better doesn’t mean that the something actually worked. Maybe the patient would have gotten better anyway. There’s also some strong psychology at work: when we do something that we expect will help us feel better, it does help us feel better. Symptoms like cough or pain or nasal congestion are all subjective. To really prove that a treatment works, it should be shown to be more effective than doing nothing. After all, why should patients accept the expense and risk of a treatment if it doesn’t really do anything more than plain water or a sugar pill?

Science-based medicine is a process that develops and improves with time. As better studies are done and more information is available, some treatments that were once thought to be effective are abandoned in favor of better treatments. Doctors should strive to offer the best and safest available treatments, based on the best scientific information available.

There are several treatments from what’s often called the realm of “alternative medicine” that have passed the tests of science and belong firmly in the treatment toolbox of physicians. These include probiotics for a variety of illnesses, omega-3 supplements for the prevention of heart disease, and melatonin to regulate sleep cycles. I don’t consider these “alternative medicine” at all—they’re just medicines, and have their own well-understood risks and benefits.

That cough study was actually done, and showed that the honey was at least as good as cough medicine at treating cough, maybe even a little better. Based on this and similar studies, we know that cough and cold “medicines” are nearly worthless, and aren’t worth the expense and risks. Good science has shown us that some treatments from the realm of traditional medicine—in this case, cough suppressants—belong in the “quackery” category. The same good science has shown us that something you might have thought of as an alternative medicine—honey—belongs in the realm of “real” medicine.

My main problem with alternative medicine is that its proponents do not share my conviction that these products need to be tested and evaluated. The world of alternative medicine seems to be littered with all sorts of goofy treatments and modalities that haven’t withstood even a whiff of scientific scrutiny. Their proponents seem very reluctant to point any fingers and say “that doesn’t work.” I’m not sure I’ve ever run across any criticism of any alternative medicine modality from any alternative medicine proponent. In the world of alternative medicine, it’s “anything goes.” This makes it very difficult to know what actually works.

In addition, there is very little oversight or regulation of alternative medicine treatments. Supplements and herbs are a billion-plus industry in the United States and other than voluntary industry programs there is no regulatory authority that ensures that what’s on the label is what’s in the bottle. There have been many cases of poisonous substances contaminating herbal products, and there’s no way to know if the product was manufactured, stored, or labeled properly. Just about anyone can call themselves a “natural” practitioner, giving advice and selling products.

A good starting point to read about “alternative health” is http://www.quackwatch.com/. Along with several sister-sites, Quackwatch does an excellent job in bringing the light of science to the murky world of alternative medicine. The articles are reliable, honest, and well-referenced.

Want some lead with your herbs?

A Boston University researcher has found that about 20% of a sampling of traditional Indian remedies sold in the United States had toxic levels of lead, mercury, or arsenic. In a study published this month in the prestigious Journal of the American Medical Association, about 200 products made by 37 different manufacturers representative of Ayurvedic Medicine were analyzed. It’s especially alarming because these are products meant to be taken daily to improve overall health. Almost all of the contaminated specimens were made here in the USA.

A daily dose of mercury can’t be good.

The FDA is specifically forbidden from regulating “herbs and supplements.” These products might contain what it says on the label, or might not; they might be contaminated with heavy metals or powerful, non-regulated drugs, or they might just contain essentially nothing at all. Their labels can make just about any sort of health-related claim without fear of regulatory reprisals, and without fear that anyone could actually expect some kind of proof that the product does what it says. No safety data is collected or expected.

Shopping in the “supplement” aisle of a big chain drug store or health food store is entirely a guessing game. Most of the products are merely a waste of money, but at least some of them are far, far worse. Beware.