Spare a thought for the 130+ individuals who lost their sense of smell after taking various zinc-containing Zicam intranasal products. The U.S. Food and Drug Administration has warned users to stop using said cold remedies, and advised its manufacturer - Matrixx Initiatives - that these products cannot be marketed without FDA approval.
But they were. Why?
Because of homeopathy, as this great Associated Press piece by Jeff Donn explains. Royal Copeland, a New York Senator, homeopath, and principal author of the 1938 Federal Food, Drug, and Cosmetic Act, discreetly amended said law so that homeopathic remedies were granted the same legal status as regular pharmaceuticals.
But here’s the sinister part: as long as a remedy is listed by the Homeopathic Pharmacopoeia Convention of the United States, it is granted full FDA approval. Proof that it works and is safe? Not needed. Just a place on HPUS’s list will do.
The AP also reports:
Active homeopathic ingredients are typically diluted down to 1 part per million or less, but some are present in much higher concentrations. The active ingredient in Zicam is 2 parts per 100. The FDA has set strict limits for alcohol in medicine, especially for small children, but they don’t apply to homeopathic remedies. The American Academy of Pediatrics has said no medicine should carry more than 5 percent alcohol. The FDA has acknowledged that some homeopathic syrups far surpass 10 percent alcohol. The National Institutes of Health’s alternative medicine center spent $3.8 million on homeopathic research from 2002 to 2007 but is now abandoning studies on homeopathic drugs. “The evidence is not there at this point,” says the center’s director, Dr. Josephine Briggs. At least 20 ingredients used in conventional prescription drugs, like digitalis for heart trouble and morphine for pain, are also used in homeopathic remedies. Other homeopathic medicines are derived from cancerous or other diseased tissues. Many are formulated from powerful poisons like strychnine, arsenic or snake venom.
Key to the matter is how homeopathy is defined. We may know it as being medicine devoid of medicine, but to define it as such would be fallacious: a 30C solution may indeed bear no active ingredient, but one diluted to 2 parts per hundred most certainly does. But Zicam’s products do not stand alone: the AP identified up to 800 homeopathic ingredients potentially implicated in health problems reported last year.
I see little point in commenting on the obvious federal legal implications regarding improperly labeled drugs, not to mention the harm caused by trading objectionably on an already objectionable concept, but in my last post, I brought forward the Medicines and Healthcare products Regulatory Agency’s decision to licence Nelsons Arnicare Arnica 30c homeopathic pillules. Well, ladies and gentlemen - assuming you can still hear me as I shout through this gaping chasm of a loophole, if ever there were confirmation that allowing medicines to be sold without any proof of their efficacy or safety is a monumentally stupid idea, this story is undoubtedly it.
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11 responses
I’m confused. All over this site we’re told that homeopathy is not medicine and not science because there’s a large element of it that’s purely belief and, in an case, there’s no active ingredients to speak of. However, you’re saying that homeopaths can and do prescribe active ingredients.
If there some active homeopathic ingredients are harmful, if misapplied, are those effective if used properly? Are there homeopathic active ingredients that work and those that don’t work?
Is this Zicam stuff a treatment prescribed and developed by homeopaths (registered or otherwise) or is it something that’s been developed by others to sell as a homeopathic remedy? Has it made its way on to a government list because it seems like a homeopathic remedy? Do homeopaths regard Zicam as homeopathic?
Unintelligent Designer,
Homeopathy is defined as a system of ‘medicine’ where substances that would bring about symptoms in a healthy person are used - heavily diluted - to treat an unwell person who already has those symptoms. The fact that there is no active ingredient in the solutions that homeopaths would typically use (Hahnemann recommended 30C and beyond) is only a prevalent consequence of their methodology, and not a prerequisite.
The manufacturers of Zicam state that their products are a 2X homeopathic solution, “packaged and distributed in full accordance with the HPUS”.
For criticism, see Dr. Iris R. Bell in the AP article. She says that most homeopathic remedies are much safer than conventional pharmaceuticals. You and me know why, of course.
Thanks for that, WH. I see what you mean. However, I was wondering whether homeopaths regard Zicam as homeopathy. This is an important point.
http://www.google.com/hostednews/ap/article/ALeqM5gQ2bZ11tGtoiKx6BO5K70Lx1ETmgD98SK27G0:
“Dr. Iris R. Bell, a psychiatrist and homeopathy researcher at the University of Arizona, Tucson, says the suspended Zicam products deliver the homeopathic ingredient right into the nose — not an accepted homeopathic method. She says the FDA should act against such products.”
She says the Zicam delivery method doesn’t accord with homeopathic practice.
The US National Center for Homeopathy says Zicam isn’t homeopathy:
http://nationalcenterforhomeopathy.org/articles/view,341
Skeptico says Zicam doesn’t sound like a homeopathic preparation:
http://skeptico.blogs.com/skeptico/2005/06/if_it_has_any_i.html
We’re talking here about unscrupulous producer of over-the-counter pharmaceuticals that makes a bad product within state-registered legal definitions.
We’re not talking about an over-the-counter preparation registered as homeopathic, not a homeopathic preparation made and prescribed by homeopaths. There’s a difference between those two things. 30C is a world away from 2x.
I think you do a disservice to the facts by suggesting that the harm caused by a state-registered pharmaceutical that’s claimed to be homeopathic provides evidence that homeopathy is potentially dangerous.
“The fact that there is no active ingredient in the solutions that homeopaths would typically use (Hahnemann recommended 30C and beyond) is only a prevalent consequence of their methodology, and not a prerequisite.”
Here, you’re offering a similar argument to the one the Zicam manufacturers use in protecting their product as homeopathic. They’re following the regulations to the letter.
I think we need to know whether Zicam is made by homeopaths and whether a wide community of homeopaths recognise it and recommend it as valid in their system of treatment. If they don’t, your linkage of Zicam, which is shown to cause harm to people, to their practice is at least unfair and at worst disingenuous.
The line of argument from debunkers and sceptics over the years is that homeopathy doesn’t (in fact, can’t) work. Either it can or it can’t. You seem to be saying that it can work. But you’re offering this opinion based on a 2x product. What about 30C preparations? Do you agree there’s a difference between 2x and 30C homeopathic products?
So how many other 2x products are there? Are these harmful? How many 30C preparations are harmful?
Science is needed here, soon.
Lastly, I think we need to know who owns Matrixx Intiatives, the company that produces Zicam? Is it a small-scale operation run by deluded homeopathic enthusiasts? Or is it a subsidiary of a larger pharmaceutical company? If it’s not a subsidiary, where did it get the capital to succesfully launch an over-the-counter medication in such a cut-throat market?
By the way, I’m not a homeopath and don’t use homeopathic remedies.
Unintelligent Designer,
What I point out is that a 2X solution may very well have an active ingredient present. This was so in Zicam’s case, because a lot of people were harmed. At no point am I saying that homeopathy works: a cold remedy that destroys one’s sense of smell is certainly not my idea of successful treatment.
My association of Zicam with homeopathy is certainly not unfair. What Royal Copeland sowed has sadly been reaped, and I have already stated that Matrixx Initiatives is “trading objectionably on an already objectionable concept”.
“The line of argument from debunkers and sceptics over the years is that homeopathy doesn’t (in fact, can’t) work. Either it can or it can’t. You seem to be saying that it can work. But you’re offering this opinion based on a 2x product. What about 30C preparations? Do you agree there’s a difference between 2x and 30C homeopathic products?”
UD I think you’re bringing up an unrelated issue. The above article isn’t about whether or not homeopathic remedies work, but the consequences of homeopathic remedies gaining automatic FDA approval. The FDA doesn’t just establish the efficacy of medical remedies, it also establishes their safety. Homeopathic remedies don’t have to go through the same long clinical trials to establish their safety before they hit the market. And in the case of this nasal spray, that means an unsafe product was let loose on the market.
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“For criticism, see Dr. Iris R. Bell in the AP article. She says that most homeopathic remedies are much safer than conventional pharmaceuticals. You and me know why, of course.”
Most homeopathic remedies are water. They are “safe” only if you’re treating for dehydration. They treat nothing else.
Once you start getting into these lower succussions, the remedies contain an active ingredient and they should be controlled by the FDA.
O Really Tom!! Have u ever tried Homeopathic Medicines??? They are not diluted but POTENTISED, which means by the process of successions given, the kinetic energy of the molecules is raised to many folds. Here it differs from simple Dilution, in which only water is added but not potentized.
Homeopathic medicines do work and many clinical trials are on to feed the rationalistic minds. Under WHO only trials have been conducted and it had been recommended to use them. How can someone treat ailments ranging from coryza, cough, acne to asthma, pneumonia, kidney stones by Placebo Effect… This type of comments surely doesnot suit to intelligent people li you, Tom!!
And Homeopathy is surely a hit on fortunes of pharmaceutical Companies due to it’s cost-effectiveness that’s why giants are behind it…
Every year there is 20-25% economic growth and homeopathic Heathcare industry is going to be somewhere near 52,000 crore by 2017, just because of it’s Placebo Effect… FUNNY!!!
I recommend you a thing, please try this so called Placebo under a good reputed clinician and feel changes in you.
Good Luck!!
Priyanka, Good luck with that. You enjoy your homeopathic “cure” and I will enjoy modern Western medicine.
I will come to your cremation with flowers for your family. Rest in peace.
@Priyanka: “which means by the process of successions given, the kinetic energy of the molecules is raised to many folds.”
So the solution gets hotter? Well, I suppose it would really, if you go around banging it against things. I’m just not sure what possible health value that has, since it’s going to cool down pretty rapidly.