Once again, repeat after me: Homeopathy is quackery. In fact, it's what I like to refer to as The One Quackery To Rule Them All. You would think that, in a modern world and given the incredible advancements in our scientific understanding of biology, physiology, chemistry, and physics over the course of the over 200 years since Samuel Hahnemann pulled the concepts behind homeopathy out of his nether regions, it never ceases to depress me that there are large numbers of people who think that homeopathy could ever work. But they do.
A couple of weeks ago, I took notice of a, well, notice from the FDA announcing that it was considering revamping its regulation of homeopathic remedies. What? you're thinking (if you haven't read this blog before or somehow missed my post on this). The FDA regulates homeopathic remedies? WTF? Why would the FDA regulate water? The long version of the explanation is in the link above. The short version follows. Basically, when the law authorizing the FDA was amended in the 1930s, a provision was added that defined any remedy listed in the Homeopathic Pharmacopeia of the United States (HPUS) as a drug. Consequently, any magic pixie dust homeopaths want to call a remedy and put it into the HPUS gets a pass from the FDA, even though, as Jann Bellamy argues, just because the law defines anything in the HPUS as a drug doesn't mean the FDA can abdicate its responsibility to regulate it. After all, one of the charges of the FDA is to require that drugs be safe and effective before they are marketed, and it doesn't do that for homeopathy, even for homeopathic asthma remedies.
Whatever the reason, the FDA announced that it was going to hold a hearing on the regulation of homeopathic remedies in Bethesda on April 21 and 22. With the public hearing less than a week away, the FDA has released the list of people who will be giving testimony at the hearing.
I have a bad feeling about this.
Why do I say this? Consider this. I count 37 people giving testimony over two days. Can you guess how many could be considered to be on the side of science? There are only three on the list whom I can identify through knowledge or an educated guess as definitely or likely being on the side of science:
- Edward P. Krenzelok, Rocky Mountain Poison and Drug Center
- Michael DeDora, Center For Inquiry (whom I have offered advice to, as have other skeptical physicians).
- Barbara A. Kochanowski, Consumer Healthcare Products Association
As for the rest? It appears to be representatives from various naturopathic organizations, homeopaths, manufacturers of homeopathic remedies, law offices, and "integrative" medical centers where quackery and scientific medicine are "integrated" to the detriment of science. The only good thing about the rest of the list is that at least Dana Ullman isn't one of the people giving testimony. That would have truly pushed the hearing into the realm of the surreal, although at least it would have provided some entertainment value in a sad, freak show sort of way.
Still, the homeopaths are leaving nothing to chance. They're flying in a representative from the UK, specifically Peter Fisher from the Royal London Hospital for Integrated Medicine (formerly known as the Royal London Homeopathic Hospital. He's definitely a heavy hitter in the brave new world of integrating homeopathic quackery with real medicine, having chaired the World Health Organisation’s working group on homeopathy and served as a member of WHO’s Expert Advisory Panel on Traditional and Complementary Medicine. He's also Editor-in-Chief of Homeopathy, published by Elsevier, the only journal dedicated to homeopathy indexed in Medline. (If you want a giggle, just read its table of contents over the last few months.) He also serves as Clinical Lead for the UK’s National Library for Health’s online Complementary and Alternative Medicine Specialist Library, the NHS's official knowledge website for Complementary and Alternative Medicine and of the Complementary and Alternative Medicine Library and Information Service. He was awarded the Albert Schweitzer Gold Medal of the Polish Academy of Medicine in 2007. Somehow, I doubt that Fisher will be advocating stricter regulation.
What about some of the others? Given my background and blogging, my eyes weren't first drawn to the homeopaths. After all, I know what they're going to say. They believe magic is real, and they're going to try to argue that the FDA shouldn't regulate homeopathic remedies, that the FDA should leave things just the way they are. And why not, at least from their perspective? Things are just ducky for them now. The FDA doesn't bother them. No one can access the HPUS without paying a rather hefty subscription fee; so there isn't even any transparency as to how homeopathic remedies are chosen to be in the HPUS. Tighter regulation of homeopathic remedies or—gasp!—actually regulating them as drugs would be a major threat to the ability of homeopaths to practice their quackery; so it's no wonder they're flocking to the hearing. No, what I'm more interested in are some of the representatives of academic integrative medicine programs who are testifying. If you want some insight into quackademic medicine, it's useful to take a look.
The reason is simple. I want to see if any of them will defend the current hands-off approach to homeopathy. If there's one thing I've learned, it's that most integrative medicine practitioners and researchers based in academic medical centers tend to be profoundly embarrassed by homeopathy and try to deny it as being part of "integrative medicine" because it is so obviously based on magic. Remember, though. That's most, but not all. One good thing that can come from this hearing is that it's possible that one or more of these academic practitioners who've dedicated their lives to "integrating" quackery with medicine might let his true colors show by defending homeopathy.
For example, there is Adriane Fugh-Berman of the Georgetown University Medical Center. I can't say for sure which way her testimony will go, but I rather suspect it will be sympathetic to integrative medicine, given that she is the director of PharmedOut, which is known for keeping pharmaceutical company influence out of CME activities. That in and of itself is not a bad thing, but couple that with the fact that she is also very heavily into herbal medicine and has been quoted as the "other side" in news reports about Paul Offit's critical book on alternative medicine. Her attitude appears to be relatively hostile to pharmaceutical companies. That wouldn't be a bad thing (after all Ben Goldacre, someone whom I admire, is not what one would call friendly to pharmaceutical companies), but Fugh-Berman combines that with troubling advocacy:
Dr. Fugh-Berman noted that, while research is essential to discover effective treatments, it is only part of the equation in encouraging CAM. Even when physicians and consumers know that particular CAM therapies are useful, they may not choose to recommend or practice them. Dr. Fugh-Berman called for a paradigmatic shift in conventional medicine to integrate effective CAM modalities into treatment, education, and coverage. Yet, so long as the medical system remains profit-driven—and physicians unduly influenced by pharmaceutical companies—this is unlikely to occur.
Yep. That's a common alt-med trope used to make excuses for why "complementary and alternative medicine (CAM)/integrative medicine is not more widely accepted in the medical profession, and it does not give me confidence to have found her saying such things in interviews. I get the feeling that Fugh-Berman will probably be advocating mostly for the status quo. On the other hand, she does study natural products pharmacology; so maybe a curve ball is possible, the sort where she agrees that homeopathy is quackery that works through placebo effects but accepts the rebranding of a science-based modality like natural products pharmacology as somehow being "CAM" or "integrative." I doubt it, though.
Another faculty member giving testimony is Luana Colloca of the University of Maryland. She's another one whose testimony could go either way. An associate professor in the Department of Anesthesia, she's published with Fabrizio Benedetti on placebo effects. I imagine she will be likely to testify that homeopathy "works"—such as it does—through placebo effects. What I can't be sure of is whether she will conclude that this is a good thing or not. I rather suspect that Colloca was asked to testify by the FDA, given her very specific expertise in the science of placebo effects and her track record of scientific publications on the topic. She's also in Baltimore; so she's local.
There's also a faculty member from the Northwestern University Feinberg School of Medicine in Chicago, Youngran Chung from the Ann & Robert H. Lurie Children’s Hospital of Chicago, and a representative of a very quacky clinic founded by a Northwestern faculty member, the Raby Institute for Integrative Medicine at Northwestern, which is being represented by Robert C. Dumont, an "integrative pediatrician" specializing in acupuncture and homeopathy. I hadn't heard of the Raby Institute before; so I checked out its website. It turns out that it's not just the Cleveland Clinic that's offering the prescientific nonsense retconned by Chairman Mao or the quackery that is functional medicine. It's there at the Raby Institute, overseen by a clinical faculty member of Northwestern.
To be fair, the relationship between the Raby Institute and Northwestern appears to be arm's length at best. The founder of the Raby Institute, Dr. Their Raby, started her career combining quackery with real medicine by getting Northwestern's Center for Integrative Medicine off the ground. Then after several years running the center, she apparently decided the grass was greener on Michigan Avenue and founded the Raby Institute. Right now, she's still a member of the Northwestern Physicians Group, has privileges at Northwestern Memorial Hospital, and remains clinical faculty for the Northwestern University Feinberg School of Medicine in Internal Medicine and Geriatrics, but appears to be in private practice now in a nice swanky office on Michigan Avenue just a few blocks from Northwestern in downtown Chicago offering woo to the well-off sort of Chicagoans who tend to go to an address on North Michigan Avenue for their health care needs. In addition to the usual TCM treatments like acupuncture, the Raby Institute even offers cupping, which is one of the more ridiculous nonsensical treatments out there, and claims to be able to treat everything from AIDS to cancer to cardiac disease to infertility with TCM! Oh, and it also offers homeopathy, as well as the faith healing equivalent known as "energy medicine," including reiki, qi gong, functional medicine/a>, vibrational medicine, craniosacral therapy, and healing touch. Maybe it's a good thing that Dr. Raby is no longer affiliated with the Center for Integrative Medicine. Perhaps she had become too quacky even for Northwestern. On the other hand, she's probably why the center still offers naturopathy, acupuncture, functional medicine, chiropractic, and other nonsense mixed with some sense.
Call me crazy, but I get the feeling that representing the Raby Institute Dr. Dumont will not be testifying against homeopathy, given that Dr. Raby has a naturopath, acupuncturist, and energy healer on her payroll and that Dr. Dumont has shilled in the past for a major manufacturer of homeopathic remedies, Boiron, as an expert witness. Hilariously, in open court he admitted that no one in the homeopathic community has a hypothesis for how homeopathy "works," including him and that he'd have the Nobel Prize if he did know. Maybe he will be able to provide the entertainment value that is missing without Dana Ullman testifying.
Even though Dr. Dumont is not Northwestern faculty (although his partner and the founder of the Raby Institute is) what about Youngran Chung? She's pediatric pulmonologist at Northwestern's Lurie Children's Hospital of Chicago who's listed as being interested in CAM, asthma, chronic cough, and cystic fibrosis. Her profile lists her thusly:
Integrative medicine (Complementary/Alternative medicine) in pediatrics. I am board certified by the American board of Integrative & Holistic Medicine (ABIHM). Having been trained/certified in Medical Acupuncture,Homeopathy, and Medical Hypnosis, I am interested in the integration of Complementary/Alternative medicine modalities along with conventional medicine to provide safe and effective ways to treat patients.
Another profile describes her thusly:
She integrates homeopathy extensively in her pulmonary practice, and has authored articles in medical journals as well as book chapters on the topic of homeopathy. She has given symposiums and presentations on homeopathy at conferences in the United States as well as abroad.
Yes, Northwestern University has a bona fide physician/homeopath on it damned faculty in the Department of Pediatrics treating the children of Chicago! In fact, it's right there on her Northwestern Medicine profile that her clinical interests include "Acupuncture, Asthma, Cough, Cystic Fibrosis, Homeopathy, Medical Hypnosis." Interestingly (well, not really), she's presented a poster with Dr. Dumont entitled Homeopathy, an Effective, Practical, and Safe Therapeutic Approach: Principles, Evidence and Examples of Practical Application. Get a load of the abstract:
Homeopathy has been in use for more than 200 years and is currently practiced by thousands of physicians worldwide. Homeopathic medicines are safe, non-toxic, without adverse effects or drug interactions and are regulated as drugs by the US Food and Drug Administration in the United States. While homeopathy is gaining popularity in the United States, there is poor understanding and misconceptions about it among physicians. Many medical conditions (eg, pertussis cough, recurrent croup) do not have effective drugs and cannot prevent recurrences or require medications with undesirable side effects. Due to the nature of its preparation, homeopathy is an extremely safe modality that can be used as first-line treatment for many acute or chronic conditions or in conjunction with conventional or other nonconventional therapies. While formal training is necessary in order to use homeopathy for chronic conditions, many acute medical problems can be effectively treated by physicians with a basic understanding of homeopathic principles through the use of simple protocols for certain commonly encountered conditions. The poster will cover basic homeopathic principles, review the evidence for efficacy, and present cases from the authors' experiences. Protocols for common acute medical problems that the participants can use immediately in their clinics or offices will be presented and discussed.
In fact, Dr. Chung is apparently married to Dr. Dumont. They've presented at the same conference before, and her presentation was Homeopathic Treatment of Psychosomatic Disorders of a Respiratory Nature : A Case Series while his was, horrifyingly, Use of Clinical Homeopathy in Autism Spectrum Disorder. There's even a presentation by Dr. Chung posted at the Chicago Asthma Consortium website on CAM that credulously discusses homeopathy, even going so far as to describe a case of a 14 year old with sore throat including burning, stinging pain that was worse with warm food and drink but better with cold food or drink. Her prescription? Homeopathic APIS (bee venom), because like cures like and bee venom causes burning and stinging pain. She even has a slide that shows various homeopathic dilutions up to 1M (or 1,000C), which is a 10-2000 dilution, admitting that everything over around 12C (10-24 dilution) is beyond Avogadro's number.
I repeat again. This is a member of the faculty of the Northwestern University Feinberg School of Medicine! I remember the last time when I did my Academic Woo Aggregator, homeopathy was uncommon in medical schools and academic medical centers. I wonder if that's the case now. In fact, I really should update the Woo Aggregator. In the meantime, all I can do is lament that Northwestern would have practitioners of homeopathy on its faculty such as Dr. Chung, who practices the prescientific vitalistic sympathetic magic known as homeopathy and Dr. Raby, a credulous doctor who has monetized nonsense. At this rate, Northwestern might as well rename itself Hogwarts. Even worse, in my opinion they're both using the academic reputation of Northwestern to promote homeopathy as they testify with the likes of Peggy O'Mara, publisher and editor of Mothering.com, one of the wretchedest of the many wretched hives of scum and quackery on the Internet and Nancy Peplinsky, founder of the Holistic Moms Network, which is just as bad as it sounds from the name. If you want to know how deeply quackademic medicine has infiltrated medical academia, just look for homeopathy in academic medical centers.
As I said, I have a bad feeling about how this hearing will go.
That makes it all the more critical that as many people and organizations devoted to science-based medicine as possible submit written commentary before the deadline. I described how to do it. Jann Bellamy described how to do it. Mark Crislip provided an example of how to do it. So just do it. Otherwise, the preponderance of testimony from homeopathy supporters is likely to have considerable influence. The status quo will continue, and magical "cures" for what ails you will remain unregulated.
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It appears that FDA has stacked the deck in the direction they want to go. Now the bureaucrats can report that the "scientific consensus" based on public testimony is that homeopathy works and no additional regulation is necessary.
I don't know the FDA, of course, but I wouldn't be too despondent.
When the House of Commons Science and Technology Select Committee considered whether there was evidence for homeopathy to be provided on the NHS, the witnesses included the following:
Paul Bennett, Professional Standards Director and Superintendent Pharmacist, Boots
Robert Wilson, Chairman, British Association of Homeopathic Manufacturers
Dr Peter Fisher, Director of Research, Royal London Homeopathic Hospital
Dr Robert Mathie, Research Development Adviser, British Homeopathic Association
Although the FDA has more homeopathy apologists, it didn't work out too well for this lot.
"Q1 Chairman:...You actually manufacture and sell homeopathic remedies. Do they work beyond the placebo effect, very briefly?
Mr Bennett: First, I need to correct you actually, I am afraid. We do not manufacture products.
Q2 Chairman: You sell them though?
Mr Bennett: We do sell them.
Q3 Chairman: So you sell them?
Mr Bennett: We do indeed sell them and there is certainly a consumer demand for those products.
Q4 Chairman: I did not ask you that question. I said do they work beyond the placebo effect?
Mr Bennett: I have no evidence before me to suggest that they are efficacious, and we look very much for the evidence to support that, and so I am unable to give you a yes or no answer to that question."
"Q7 Chairman: Robert, what is your position? You do manufacture.
Mr Wilson:We do manufacture, yes, and I represent 95 per cent of the manufacturers in the UK. Definitely we believe there is a strong case for the efficaciousness of homeopathic medicines. This is an industry that has been growing strongly. It has been around for 200 years and I think it is worth saying that in France it is a 400 million euro business and in Germany it is the same.
Q8 Chairman: So is prostitution. It does not mean to say it is right, does it? My question to you, Robert, is does it work outside the placebo effect?
Mr Wilson: It definitely does work outside the placebo effect.
Q9 Chairman: It definitely does. You have cast-iron evidence to support that?
Mr Wilson: We have many trials that show a strong efficaciousness for homeopathic medicines.
Q10 Chairman: Why do you not supply that to Boots then?
Mr Wilson: We do supply that to Boots.
Q11 Chairman: So why do they not believe you?
Mr Wilson: They do believe us.
Q12 Chairman: He has just said they do not.
Mr Wilson: No.
Q13 Chairman: He said he neither believes you or he does not believe you.
Mr Wilson: He has not asked us specifically about the efficaciousness of homeopathic medicines. Boots are a very important retailer; they sell a great deal of these products. You have also got to ask the question, if these products did not work beyond the placebo effect, why do people keep buying them? Leaving that aside, there is a trial out which was literally published in the last—
Q14 Chairman: That was not a serious point, was it? Was that a serious point you were making?
Mr Wilson: Yes, I believe, certainly, that people continue to buy products because they work for them."
It should also be remembered what Dr Peter Fisher has said about homeopathy for malaria prevention:
"The hospital's Director Peter Fisher told Newsnight "I'm very angry about it because people are going to get malaria - there is absolutely no reason to think that homeopathy works to prevent malaria and you won't find that in any textbook or journal of homeopathy so people will get malaria, people may even die of malaria if they follow this advice."
To the best of my knowledge, he has never said how he knows homeopathy doesn't work to prevent malaria.
I hope you're right.
Alan @2: The FDA is not Congress. There may be substantial pressure on the FDA from certain powerful Congressmen to maintain the status quo. I agree with Orac that the list of witnesses is not promising.
The spread of belief in homeopathy among people who have presumably taken high school chemistry and therefore ought to know better is disheartening. Do we have to resort to forbidding homeopaths from using electronic devices? Because it is not possible for both homeopathy and quantum physics to be true, and modern electronic devices depend on quantum physics for their principles of operation. A 40C dilution leaves you with about one atom out of the entire universe, and some homeopathic remedies go well beyond that.
I'll grant them that homeopathic remedies don't have nasty side effects. That's pretty much by design, and part of why homeopathy got a foothold in the first place was because most medical treatments in Hahnemann's day did have nasty side effects. (I'll also give Hahnemann a pass on Avogadro's number, which wasn't known at the time--the number is named after Hahnemann's contemporary Avogadro because the latter realized that there was such a number, which is finite.) But by the same token, homeopathic remedies essentially are placebos. It might have been a reasonable thing 200 years ago, but science marches on, and it's not a reasonable thing today.
"Mr. Wilson: I think it is worth saying that in France it is a 400 million euro business and in Germany it is the same.
Q8 Chairman: So is prostitution. It does not mean to say it is right, does it?"
Thank you Alan Heness @#2. You made my day.
Does anyone know if there is any kind of similar hearing (like reviewing regulations on generic medications) that we could see how that stacked up.
I suspect they usually do try to hear from all the various groups that may be effected by the new regulations so I'm not surprised if they have a fair number of people up and down the homeopathic food chain.
That and usually the people who are going to be regulated tend to be the ones that step forward to talk more so than those in other industries that may get an advantage if things get tougher for the other guys.
Not always. If they were just pure homeopathic remedies, yes. However since they are not regulated they can have variability in their potency (see Hyland's belladonna problem with their homeopathic infant teething remedy), can be contaminated with who-knows-what and/or spiked with actual pharmaceuticals. Then there is the indirect effect which is neglecting to seek proper medical care in lieu of taking magic water.
If only one works, no one should have a problem taking the Randi challenge. Administer it to 100 people, find the 50 that got better, done.
I have submitted a personal comment, and I have convinced the Evidence-Based Veterinary Medicine Association to submit a letter as an organization. For evil (or in this cases, stupidity) to triumph, all that is required is for good men (or in this case people who understand science) to do nothing. Unfortunately, skeptics aren't usually as fanatically driven to speak out as are true believers, so we can't expect to match the quantity of input the homeopaths will put forward. Unfortunately, of the nearly 900 comments submitted to the website so far on this issue, the vast majority say something like "I use homeopathy and it works so don't let those evil pharmaceutical companies use the government to suppress this miraculous natural therapy." *sigh*
Hopefully, the FDA means it when they say they consider the quality as well as quantity of comments.
Let's hope that those presenting on the side of reason make a passionate, interesting, and researched argument to eclipse what the others might be bringing in. The unfortunate truth is that the inherent glamour in the possibility of better cures for diseases still blinds people from reason. Homeopathy needs to be regulated. When my son was an infant, I gave him Hyland's for a stuffy nose-just because I had tried everything else...also I did not realize it was "homeopathic" until later. I just saw on the box that infants could use it. Whether or not it worked or seemed to work is a toss up (a weird syrup just may clear the nose for a while) but here's an interesting story-I had an excess drop on my finger and touched it to my lips. They started to swell like cartoonish balloons on my face. I went to the emergency room and was given a steroid shot. Now whether it was some "natural preservative," or a packaging issue, or a random coincidence of being bitten by an invisible bug at that same time, I don't know. But it seemed to have an effect on me...thankfully not my child.
Except at Hogwarts the magic actually works.
Hey, that's my usual joke!
Past 10 comments, so, apropos of the illustration, and the subject matter:
Use the Farce, Luke!
And for the hearing, a plea:
Help us, Obese One Kenobe! You're our only hope!
In the sense of not existing, sure.
Unfortunately, Dr. Chung and Dr. Raby remain clinical faculty at Northwestern; so that's not quite right. On the other hand, the Raby Institute likely competes with Northwestern's integrative medicine center as well.
I think there's a working compromise--the FDA is required to recognize preparations in the HPUS as drugs they have to the responsibility to regulate them as drugs. Citing the Hyland belladonna incident, they should simply require that makers of homeopathic products conduct quality control testing on random samples of each 'drug' lot before its released for sale, demonstrating that the active ingredient is present at the desired final concentration.
What's that you say? It's impossible to detect the presence of starting materials diluted far in excess Avogadro's number? That's one hell of a sensitivity issue with your assays--come back when you've solved it and we'll talk about releasing the lots.
BTW, make sure you're running all appropriate controls as well to avoid false positives and negatives--for example, the assay will need to be able to reliably distinguish between your final drug product and matched vehicle controls containing everything but the active ingredient.
So do I. But it's also worth considering what the situation would be if they only had a few homeopaths giving testimony: there would be cries of 'you didn't properly listen to teh homeopaths'! 'You only listened to the classical homeopaths!' 'You're not interested in listening to homeopaths, only Big Pharma shills...' You get the idea.
By inviting a large number of homeopaths and supporters they may be attempting to defuse those objections. Of course, if they tighten up on homeopathy regulation as a result, homeopaths will still complain the FDA are in the pockets of Big Pharma who want to protect their turf at all costs.
But homeopaths never seem to consider that if Big Pharma really wanted to quash homeopathy, they could buy them all out for little more than their pocket change.
But, as you say, at least they didn't invite Dana 'not credible' Ullman (http://www.chapmancentral.co.uk/blahg/2014/12/court-finds-dana-ullman-n…).
I've been having a look at the comments submitted to the FDA, particularly those submitted by homeopaths. I've already submitted one correcting what Camilla Sherr and another have said about Ullman's hilariously wrong HuffPo article about the Swiss homeopathy report. I suspect there's much more fun to be had there...
Dumont nonetheless has no Northwestern affililation.
I like that solution, although I'm sure homeopaths will have some convenient excuse why that can't be done.
As I've said many times before, the reason homeopathy appeared to "work" better than conventional medicine back in the early 1800s was because what passed for medicine back then was so nasty: bleeding, purges, treatment with metals like antimony and cadmium (even mercury), and the like. Doing nothing (which, let's face it, is what homeopathy is in essence) was not infrequently better than the toxic and ineffective treatments of the day. As "conventional" medicine improved, becoming more effective and safer, doing nothing was no longer a viable option, particularly given advances in science that demonstrated conclusively that homeopathy couldn't possibly work.
In any case, I still can't believe that Northwestern has a physician who practices homeopathy on its faculty treating children and that it had a physician who got its integrative medicine center together and ran it for several years, yet clearly believes in homeopathy, is still on faculty, and still has hospital admitting privileges.
Link? I feel in the mood to hurt my brain later.
I think this is the link to the submitted comments.
So, not only are you anti-homeopathy, but you're anti-WEALTH too!! Can't you see these folks just want to make a living selling water to people? And if the FDA regulates it, it must DO something, therefore it'll work even better after these hearings!
It's not at all clear to me that we should read this as the FDA stacking the deck one way or the other. The way the announcement read, the witness line-up was based on who registered. The FDA just reserved the right to limit or combine witnesses based on time and space considerations. It shouldn't be surprising that homeopathy proponents, who have a lot on the line financially here, would flock to the hearing.
Maybe I'm misreading it and there were also a large number of FDA invitees.
But in any case, the record will be open until June 22. I hope that supporters of science-based regulation will file written comments before then. It may not get as much attention as a public hearing, but building the administrative record to support decent regulatory action is really important.
I'm reminded of what Harriet Hall said at NECSS about chiropractic. They never remove anything; they just keeping adding more and more stuff. Same with homeopaths. Have there been any homeopathic products that they've decided doesn't actually work and discarded it?
But if they're going to insist that their products perform as well or better than those manufactured by Nig Pharma, surely they can't object if the FDA holds the 'drug' lots they manufacture to exactly the same release standards it demands for drug lots manufactured by Merck, Astra-Zenaca, Glaxo-Smith Kline, etc.?
Someone needs to read into the hearing record the details regarding homeopathic provings of starlight, shipwreck, etc.
Or homeopathic plutonium or Saturn!
I've used homeopathic remedies for many years to help with a myriad of troubles ranging from people agoraphobia, headaches from Morgellons which is caused by a live fluke and acute gullibility syndrome. As long as I believe and get the 200C dilution (no nasty chemikillz) it will always work. I will be added my voice to the FDA on this important matter
I notice that when I drink too much water I feel bloated. If when I did so, I immediately drank another 8 ounces of water, diluted and succussed in water to 30C, I'd rapidly stop feeling bloated, right?
Isn't that how it works?
I added a comment on for FDA:
(not the same as Beth #24)
I see what you did there.
@Orac #21, @KayMarie #22
Your link doesn't seem to work, but this appears to: http://www.regulations.gov/#!docketBrowser;rpp=25;po=25;dct=PS;D=FDA-20…
I've submitted two comments: the one correcting Ullman's article on the Swiss homeopathy report and another silly one correcting a comment about the Royal London Hospital for Integrated Medicine and the use by the Royal Family. Waiting for them to be approved...
Actually, in that case the homeopathic remedy would work fine.
It would be water, since water makes you bloated. Diluted 30C or 200C ...
By the time you got through all that succussing and diluting and put a bit of your powerful remedy into a vial and drank it, the water you drank earlier would long since have passed into your bladder, you would have peed it out and you would feel fine.
Hmmm...That seems to be dynamic as well and doesn't work now. Probably best to search http://www.regulations.gov/ for
Homeopathic Product Regulation: Evaluating FDA’s Regulatory Framework After a Quarter-Century
then look for the (470-odd) comments!
@Alan, both links work (mine is one layer out from yours so you need another click to get in).
Strangeness abounds, maybe someone needs to sprinkle the server with some homeopathic something or other.
@ Kay Marie:
But what would cure 'strangeness'? How is that 'proved'?
From a vibrational standpoint perhaps gathering up some strange quarks or something that radiates strange quarks.
From a pharmacological standpoint I'd think something like locoweed or jimsonweed or any of the other weedy things that can make the cattle go strange if they graze on them.
Ah, but I purchase only the finest quality homeopathic water from Boiron so it's all ready to go...
Can we get Dara O’Briain to go? And what’s Bill Nye doing now that he’s finished our little gig last week?
Failing that, I will write and thanks for the suggestions from the SBM writers.
@Orac Did you see that some of the presentations (or summaries of them) for the hearings have already been published, including those by Fisher, the AIH, NCH and Banerji?
There's an even better reason: "homeopathic vaccines" are nosodes [WARNING: Healthy Home Economist]. As I've mentioned before, these are very low hanging fruit (or pus, whatever).
I'm confident whoever's putting on this show for the FDA has some kind of agenda, though I can only guess what it might be. In any event, the hearing is likely a response to recent media attention to OTC alt-med products marketed by national chains not even containing what they're supposed to, and having various other questionable stuff in them intsead. The most logical possibilities for a response, it seems, would be 1) proper regulatory social responsibility, seeking to change the status quo and reel in the marketing of any-old-bs as a 'homeopathic remedy', 2) to deflate a potential political issue by protecting and validating the status quo via some sort of 'expert re-assurance' 3) to test the political sensitivities in play as a sort of experiment, to see which way the wind is blowing.
Given that there are political sensitivities involved, and no desired outcome is a 'slam dunk,' regardless of what the FDA PTB might want I'd expect the testimony list to look similar, and to NOT be heavy with sbm advocates. Specifically, if the idea is to justify increased regulation of homeopathy, that has to be accomplished in a POLITICALLY acceptable way. Just as 'only Nixon could go to China', political initiatives again credibility when a reversal of expectation is involved. The most POLITICALLY persuasive voices against homeopathy, as such, will be those who have some other Alternative/Complementary/Integretive cred.
Remember, it's politics; not science, and so it has to play in the press. If a bunch of sbm advocates declare 'homeopathy is magic that can't possibly work' that has no news value whatsoever. You get media play from 'man-bites-dog'; i.e. 'Even the Integrative Medicine community calls homeopathy a joke!'.
Now, I have no clue how stupid any of the 'quackademics' on the docket may be, how deluded they may be about how much CAM they can 'integrate', but I continue to see Integrative Medicine in quite different terms for Orac – not as an infection of woo that can spread throughout the host, but rather a pragmatic political negotiation in which the parties have to give up something to get something else.
How much stake does 'Integrative Medicine' in general have in homeopathy specifically? If the 'quackademics' have any practical sense at all, IMHO they'll throw the homeopaths under the bus for even the smallest shred of broader legitimacy.
Possible analogy: Iran nuclear deal. Orac is taking the Bibi role, 'we cannot let the bad guys have any respectability whatsoever, no matter how much they concede!' The FDA may be trying to be as John Kerry as they can: 'if we have a verifiable deal that defangs them, then we can let them have a very limited seat at the table.'
If I had to guess, I'd guess that's the script: it's all but a done deal pee-arranged with the 'quackademic' 'heavy-hitters', and the hearing will be just be political theater following that already-written narrative. But I certainly don't enough to guess with any confidence. We'll see, I guess.
I remain aggravated that unlike USP 35, I can't find a library anywhere that actually has HPUS as a holding.
Who knows what garbage lurks in the heart of HPUS? The Shadow isn't around, and I don't have a Franklin to blow a day on (even assuming that the rental product isn't crippled).
Luke we're gonna have company!
It seems doctors from Stanford and North Carolina are trying to put a little pressure on Columbia about Dr Oz.
I see here a misrepresentation of homeopathy as "just water". But actually, the water evaporates from the granule and what remains is sugar, a potent pharmacological agent.
Daniel Corcos: I would like to remind you of a time-honored practice on the internet. When one posts a jape such as yours about sugar as a pharmacological agent, it's best practice to include a jape indicator.
A traditional jape indicator would be an emoticon such as ;-} (I prefer one with a THORN character, ;-Þ aka U+00DE (222)). A newer usage is the </s> pseudo-html markup.
The absence of a jape indicator runs the risk of the reader taking you seriously, with consequent damage to your reputation.
You mean something like canned laughter?
Anyway I don't think that being taken seriously would damage my reputation and it could get me a lot of money from the sugar industry, enough for funding my Universal Cancer Treatment.
Daniel, your reply shows that you don't give a fig about your reputation; and a "Universal Cancer Treatment", apparently based on sucrose (or a sucrose derivative) certainly would not endear you to the sugar industry. Currently, sucrose is regulated as a foodstuff; you seem to wish for funding from the "sugar industry" to have it regulated as a pharmaceutical. Fat chance. (Well, maybe, you could partner up with Food Babe to extort some moolah from them; I wouldn't recommend that approach.)
You do not enhance your reputation, either, by citing a youtube (i. e., entertainment) piece in lieu of serious (written, reviewed, published, checkable) information.
No jape indicator: your pathos is not worth sarcasm or snark.
No sucrose in the Universal Cancer Treatment:
Saw a story about it on the news this morning. Columbia is hiding behind the "we want to respect our faculty's right to free speech and academic freedom" shield.
Academic freedom is important, and all, but where do you draw the line?
Pharmaceutical Interests to Secretly Testify at USA Food and Drug Hearing on Homeopathy | Official Homeopathy Resource
Um, how is it secret if they are listed on the public agenda?
Or are they closing the doors for them but no one else??
Amazing that all of this super-secret conspiracy stuff is so widely available on the most public forums available.....
@Todd W and Orac,
It looks like we spotted the same news last night. My notice was probably later because I work a late shift.
Good article this morning.
On another topic but Orac's specialty, my wife and I have been doing a bit of craft work lately and I saw an ad in a crochet magazine for a group raising money to support David Katz from Vermont, who has a fair number of PubMed citations such as this one.
Ending the need for chemotherapy for breast cancer (and other types) sounds a bit woo-ish, but I didn't see any red flags to confirm that.
He seems to be very interested in locating sentinel nodes, but the details are way deeper than my knowledge of biology or medicine allow me to evalutate.
Here's the group.
Perhaps some discussion at the other blog might be appropriate.
I looked at the comments on regulations.gov. Overwhelmingly, they are from people worried that their homeopathic remedies are going to be taken away from them.
All that is wide of the mark. It seems very unlikely that FDA would make OTC homeopathic remedies illegal, or even prescription drugs. I don't want them to do that, and I don't think many people do.
Just, hopefully, regulate the quality better, and reform the labeling and advertising for homeopathic products so they're less deceptive.
What they mean is that Big Pharma are secretly telling CfI what to say on their behalf rather than be brave enough to turn up in person...
But what they all never realise is that if - as they frequently claim - Big Pharma has the FDA in its pocket (and Washington, of course), then why bother with the façade of a hearing?
IIRC, Katz came up in a talk at NECSS by one of Orac's near and dear friends. I don't have my notes with me, but IIRC, he's affiliated with Yale and has been a big proponent of naturopathy and integrative medicine at Yale. Of course, could be a different David Katz, too.
OK, I posted one. I tried really hard to tamp down the snark, although I'm sure the concern troll sound of the snark will give it away.
Just posted a comment at the FDA site:
"I urge the FDA to the hold Homeopathic medications to the same standards of efficacy and safety that it uses for pharmaceuticals. Products that have no evidence for effectiveness should not be on sale on pharmacy shelves.
A kind word and empathetic ear can go a long way towards helping patients cope with their illnesses, and doctors and practitioners of alternative medicine alike should utilize these healing tools along side proven surgical, pharmaceutical, and manipulative therapies. But when a provider peddles a placebo for profit, either by design or by ignorance, that provider is committing fraud on their patient. Selling placebos, obscured by obtuse labeling and terminology, is fraud, and such a practice is no better than that practiced by snake oil salesmen of a century ago. The FDA was created in order to protect the public from ineffective and dangerous concoctions promoted as medications and it is time for it to protect the public from the lie called homeopathy. "
I see the comments here are dominated by homeopathy supporters. It appears that PT Barnum grossly underestimated.
(I left that last part off my comment, although I was very tempted...)
I think this comment is my favourite so far:
"You people should be ashamed! You have no ethical business "pimping" for the deadly pharmaceutical industry! Keep Your Hands Off of homeopathic remedies that have worked for millennia! Butt Out! Thank for your kind attention!"
Only an order of magnitude off on how long ago homeopathy was invented. Sigh.
More evidence people have no idea what homeopathy is and how it differs from everything else.
If I were part of the hearing committee, I'd offer each of the pro-homeopaths a challenge: I'd give them one vial each of 30C Arnica, 30C nux vomica, and plain water (randomly labeled as A, B, and C) and ask them to demonstrate how one can tell the difference between them.
Orac, is the final paragraph missing some hyperlinks? It points out several places others have explained how to file a comment but doesn't link to those places so readers can avail themselves of the advice.
@JGC #65...Oh to be a fly on the wall when the homeopaths whip out the dousing rods...
It's a homeopathic article of faith that Hippocrates advanced similia similibus curantur. One that collapses upon cursory examination, mind you (which I'm too lazy to redo at the moment), but so does everything else, so why not?
See here (and here).
That's not David Katz, it's David Krag. He does not appear, at first glance, to be a crank.
You might find this exchange at a UK House of Lords Science and Technology Committee hearing in 2007 amusing:
Ms Chatfield: I am Kate Chatfield. I am here to represent the Society of Homeopaths and I am a senior lecturer in homeopathy at the University of Central Lancashire.
Q538 Lord Broers: I have a simple, technical question about homeopathy and drugs. Is it possible to distinguish between homeopathic drugs after they have been diluted? Is there any means of distinguishing one from the other?
Ms Chatfield: Only by the label.
Orac said, "I like that solution, although I’m sure homeopaths will have some convenient excuse why that can’t be done."
Of course it cannot be done. You see, once water remembers what has been added, that memory will show up on a mass spectrometer, giving the appearance that the preparation is more than just water.
Jeeze, it's like you don't even know how homeopathy works. You're not supposed to test it at all anyway - the negative thoughts that cause your doubts of effectiveness and purity will infiltrate the magical water and render it ineffective. Indeed, this is why homeopathy seems to fail in clinical trials (the skeptics aren't believing hard enough), and why you *must* let us sell the stuff without any quality control or clinical trials. Think of the children!
They don't really have the power to do that in the first place. What they do have is the authority to enforce existing law. And sorely limited resources.
or even prescription drugs.
There already are Rx-only homeopathic drugs (and they're all drugs). The authority to make this distinction, however, has inexcusably been delegated to HPCUS.
Bob, raise your hand if you can find anybody in this room that adheres to the believe that this is a Russian water tenticle:
(Scene from James Cameron's Abyss, 1989)
Hmmm...I commented several days ago, but they don't seem to have been published yet. I replied to two separate comments as that seemed to be the only way - can someone help me by pointing out where I can submit a completely new comment? I just can't see it!
You win the internet :)
Dr. Boli has been covering homeopathy this week.
I like this one:
Maybe regulations should be on side-effects:
Imagine for instance, that the homeopathic preparation contains trace amounts of another substance, then this substance would be even more diluted than the drug and thus would be more effective. If the other substance is against autism
(http://homeopathyplus.com.au/reversing-autism-part-1/), it is likely that higher dilutions would cause autism, explaining in part the intellectual disabilities of homeopathy users.
Homeopathic remedies do indeed remember their "active ingredient" - it's listed on the label.
If indeed Boiron et al actually do obtain duck liver extract, nasal mucus, or whatever from somewhere, and do all those dilutions.
But do you really think they have a room someplace where they start with some phlegm (say), solemnly add water, shake, etc. etc.?
1. If they didn't actually perform serial dilution and succussion, that would be fraud. Major manufacturers of homeopathic remedies are not likely to risk the consequences of such a massive fraud.
2. The people who run such companies are, to a large extent, true believers.
3. The process for serial dilution and succussion is now highly automated, so there's no good reason NOT to do it.
I feel for the engineers who designed that.
Homeopath: We need an industrial process for serial dilution and shaking for manufacturing medicine.
Engineer: Sounds great. I've always wanted to work on something that has the potential to really make a difference.
Engineer: OK we're finished. By the way what kind of medications are you manufacturing here?
Homeopath: Homeopathic ones.
One might further note that Boiron's flagship product, "Oscillo," is prepared by Korsakovian dilution, i.e., simply discarding the intermediate dilutions, greatly simplifying the process.
There's a fairly extensive report to shareholders or something that I've turned up before regarding their environmental footprint; maybe I'll be able to find it again, but there's little doubt in my mind that they're actually walking the walk.
So Boiron or whoever really is getting phlegm from someplace? Maybe one of their employees coughs it up for them?
They really bought duck liver extract (whatever that is) at some point?
What are the company(s) that sell these "active ingredients" for homeopathic remedies?
this looks familiar (PDF), but I don't know that I'm going to follow it down.
Here are some homeopathic active ingredients:
Now I know there is not a company that sells positronium.
And truly, they buy plutonium nitrate? Don't only terrorists do that?
Smallpox pus???? Another terrorist item!
I gather that many homeopathic remedies are prepared that way, with the assumption that about 1% of the solution sticks to the side of the vial when dumped out.
It's denoted by "CK" rather than just "C" on the labeling. The fact that this obscurantism remains while alchemical Latin barbarisms have long been deemed inadequate is something that might bear a considered take if one were to submit a written comment (assuming they still exist per se).
The basic observation is clearly not novel, but following that history down and looking for specific parallels might be, if there's really a tier above "random Web comments."
Now I know there is not a company that sells positronium.
My understanding of homeopathic positronium is that someone had the opportunity to leave a phial of water near to a β+ radionucleide. Positrons emitted as radiation very shortly encounter an electron within the neighbourhood, and the two form an atom of positronium for 10E-7 seconds before mutually transforming into a pair of gamma-ray photons.
So what that water was actually exposed to was gamma rays, but that is close enough for homeopathic purposes.
But the real question is this: is there a company which sells syphilinum?
Korsakovian dilution is the only way to avoid Korsakoff's syndrome, the enemy of water memory.
And they don't have to buy anything to companies: they have hyper concentrated stock solutions for centuries.
M O’B @81 and Narad @ 83
Thanks to your comments, it has occurred to me that the state of California should make the production of all homeopathic remedies in the state illegal as long as we’re still in this drought. http://www.usatoday.com/story/news/nation/2015/04/18/california-drought…
In case of drought, water can be replaced by high dilutions of Sodium Chloride.
There are a large number of pro-homeopathy comments at the FDA site- very sad.
"There are a large number of pro-homeopathy comments at the FDA site- very sad."
If I find this hilarious, is it bad?
Is anyone else watching the hearing live?
That seems very unsatisfactory, even in batty homeopathic terms. Gamma rays, being photons, are very simple. The only information they carry is momentum, spin and their direction of travel. None of those are specific to positronium; even the momentum would depend on the momenta of the positron and the electron it combined with.
They really needed to consult with a physicist on this one.
It sounds like a fun adventure hunting down these homeopathic ingredients. They could make a TV series out of it; one time, hunting down the gallbladder of a bear; another time, purifying salt to obtain sodium-22 to make positrons, etc. Like Monty Python crossed with the witches of Macbeth.
Thanks, Narad and Todd W.
He's been at Vermont for over 30 years now and seems to be a good surgeon and legitimate researcher.
His current focus seems to be using radioactive tracers to locate sentinel nodes for excision to help prevent metasteses from breast cancer.
That seems very unsatisfactory, even in batty homeopathic terms.
Do not forget the wonder and the glory that is Homeopathic Black Hole.
It sounds like a fun adventure hunting down these homeopathic ingredients. They could make a TV series out of it
MAKE IT SO!!
I'm pretty sure black holes don't dilute.
At last! My two comments have finally been publisged:
The Swiss homeopathy report: http://www.regulations.gov/#!documentDetail;D=FDA-2015-N-0540-0916
The Royal London Hospital for Integrated Medicine: http://www.regulations.gov/#!documentDetail;D=FDA-2015-N-0540-0925
You've either got at least* one too many there or not nearly enough.
^ Please ignore the suggestion of a footnote.
@ JP #90
You can purchase Boiron Syphilinum (Luesinum) 30C 75 30c pellets on Amazon
Hahnemann Labs remedy list include Microwave and Xray:
Actually para-positronium, the spin-zero state, apparently does result in gamma ray photons of a specific energy - 511 KeV.
And at the end of each adventure, they solemnly succuss and throw it all away!
Make that popular and funny, and it could discredit homeopathy in people's minds.
Who are you Orac..? This was the most negative, snarky & bullish read I've had in a while. I would be questioning where your 'feelings' come from if I were you.
"Who are you Orac..?"
Another who failed the intelligence test on the worst kept secret on teh internets! Probably dos not know different colored words are links to other pages.
Would this be an issue that a Nu-Me pendant could help with?
The next time any kind of public hearing or legislative inquiry into the merits of homeopathy occurs, PLEASE do this: I suspect that all you would have to do to convince people of its absurdity would be to get them to make one of those so-called "remedies" themselves.
Empty glass jars of Starbucks brand Frappuccino are perfect for this. They're about 250 cc each. Drink the precious coffee, then save up the bottles (and the lids.) Clean them out and fill each of them with about 225 cc of water. If you add 25 ml of something to that--whatever you're going to make a homeopathic dilution of--you'll have a 1:10, or 1X dilution. Alternatively, you can fill the jars with about 247.5 cc of water, and then add about half a teaspoon of whatever you're going to make a homeopathic dilution of to it: that'll make a 1:100 dilution, or, by homeopathic nomenclature, a 1C dilution.
The main hallucination underlying homeopathy is that it doesn't matter what is going on inside your body, or what causes a disease. Bodily systems and chemical pathways don't matter. The only things that matter are the disease symptoms. According to their system of hallucinations, an extremely dilute solution of a substance that causes the same symptoms as a disease will, if the solution is shaken a certain way, cure that disease. This "like cures like" is also the basis for what is called black magic, or witchcraft.
In other words, coffee can cause insomnia, right? By homeopathic "logic," an infinitely dilute solution of coffee will cure insomnia. Make a 1C (=2X) dilution of coffee, then use some of that dilution to make another dilution, a 2C dilution, and so on. Remember, diluting it is not enough. Before re-diluting it--and remember, according to their hallucinations, each successive dilution results in a stronger "remedy"--you have to do a "succussion," which is homeopathic nomenclature for mixing, a la James Bond: shaken, not stirred.
Do this in front of a committee. Invite the chairman or other personages to help. Go there with a few gallons of water, a bunch of empty Frapuccinno bottles, a teaspoon, and whatever you want to use to make your dilution of.
I'm not sure how many successive dilutions you'd have to do like that in front of people, but surely it wouldn't take too long for anyone with a mind to realize how absurd homeopathy is with that kind of demonstration. After the third or fourth set of dilutions, ask the committee if anyone there believes that the super-diluted solutions they're looking at would cure anyone's insomnia. If anyone says yes, suggest that that person needs to be visited by certain professionals with white coats.