Yesterday the FDA advised the public not use use three Zicam products because they have been related to nerve damage and loss of smell.

  • Zicam Cold Remedy Nasal Gel
  • Zicam Cold Remedy Gel Swabs
  • Zicam Cold Remedy Swabs, Kids Size

Debrorah Autor, Director of the FDA’s Office of Compliance, laid out a pretty firm statement today when she said “consumers should stop using these products immediately and should discard or return them.”  Here’s a copy of the FDA’s letter to Matrixx Initiatives, the company who markets Zicam and other homeopathic “drugs”.

Zicam was an over-the-counter (OTC) product that had applied to the FDA as a homeopathic drug which means that it didn’t have to go through FDA approval to get put on the shelves.  Here’s the FDA’s Compliance Policy Guide (CPG) concerning homeopathy, I recommend you do not read it.  Well maybe if you’re a policy buff you would get into this but it really makes my head spin.

Homeopathy is truly a pseudo-science.  Many physicians and senior researchers attack the practice with more vitriol than a Hitler speech and even in my young scientific career I can easily see how the goal of homeopathy is to co-opt scientific ideals into a completely mystic form of treatment.  You can go all over the internet and find out why homeopathy is ridiculous but I feel the need to torture myself and look into the policy of homeopathy and how it relates to the FDA, specifically OTC products.

The CPG says:

Today the homeopathic drug market has grown to become a multimillion dollar industry in the United States, with a significant increase shown in the importation and domestic marketing of homeopathic drug products. Those products that are offered for treatment of serious disease conditions, must be dispensed under the care of a licensed practitioner. Other products, offered for use in self-limiting conditions recognizable by consumers, may be marketed OTC.

Self-limiting conditions are like the cold and other diseases that are not terminal.  So for the multitude of these conditions that medicine has identified there is a huge network of “medications” that do not have to be regulated by the FDA as long as they meet the guidelines of the Homeopathic Pharmacopeia of the United States (HPUS).

I ventured over to the HPUS site to look up what the regulations were to get licensed as an OTC product.  The first thing that turned me off was that they ask for donations on their home page.  The FDA, NIH, CDC, basically all legit scientific and medical regulatory organizations don’t do this, why exactly does homeopathy need donations?  My guess is because they can’t get enough funding because they don’t do any science or medicine.  They rely on the people who buy their bullshit products to keep their organization running.

On to the guidelines:

During the period, the FDA viewed all homeopathic remedies as prescription drugs. From 1982-1988, the industry, professional and consumer members of the community through the American Homeopathic Pharmacists Association (AHPhA) worked with the FDA in the development of a regulatory framework called a Compliance Policy Guide (CPG). Although the community didn’t get every provision that it sought, it is argued that the community obtained about 80% of its requests.

So I tried to get through the guidelines and honestly this is as far as I made it.  The whole goal of this organization was to wrestle regulatory control from the FDA and more easily market their “drugs” (read: water) to consumers without having to find some quack of a physician that would prescribe this nonsense.  It was pretty smart too, establishing labelling and safety guidelines so that they could control the production and regulation of these drugs outside of the scope of the FDA.

In fact, this is just what we are seeing with the Zicam recall; it is in no way a homeopathic drug because it actually does something!  It has an active ingredient(zing gluconate, which was labelled as zincum gluconicum, wtf?) that has shown (along with other metals) to be toxic to nasal epithelium.  I tried to track down some trials on Zicam and their website has a link for “Zinc nasal gel for the treatment of common cold symptoms: a double-blind, placebo-controlled trial” which takes you to the dreaded “404 page not found” screen.

Who knows how many other “homeopathic” drugs have ingredients that are active in your body?  I know the physicians you are seeing don’t know, and that seems like a pretty serious problem if you are concerned about drug interactions.

It is unfortunate that the FDA has little to no recourse unless physicians and consumers report negative side effects to go after these drugs.  From the letter to Matrixx Initiatives again:

We acknowledge that many homeopathic drug products are manufactured and distributed without FDA approval under enforcement policies set out in the FDA’s Compliance Policy Guide entitled, “Conditions Under Which Homeopathic Drugs May be Marketed (CPG 7132.15)” (the CPG).  The enforcement discretion set forth in the CPG is not unlimited, however.  The CPG states that it “delineates those conditions under which homeopathic drugs may ordinarily be marketed in the U.S.” (emphasis added)  The qualifying word “ordinarily” indicates that the CPG specifically contemplates that there may be circumstances where a product that otherwise may meet the conditions set forth in the CPG may nevertheless be subject to enforcement action.

Good thing they put that word “ordinarily” in there or else they may not have recourse here.  If you still think the FDA has a good amount of control over these products then maybe this will help you reconsider.

Specifically, FDA has received more than 130 reports of anosmia (loss of sense of smell, which in some cases can be long-lasting or permanent), associated with use of these products…[snip]…In addition to the reports FDA has received directly from consumers, the agency is aware that Matrixx appears to have more than 800 reports related to loss of sense of smell associated with Zicam Cold Remedy intranasal products.

Wait, wtf?  There were more than 650 reports of anosmia from this drug that the FDA didn’t even have?  Are you starting to get the picture here?  This is dangerous stuff, it may just be your sense of smell this time but what about all those homeopathic drugs that you swallow?  What is in those products? What do they even do in your body?  How reactive are they with other drugs?  What indications and contra-indications are associated with their use?  We have no way of knowing this because there is no formal investigation into these drugs.  A quack organization with profits on the line needs these drugs to sell, they need to push these drugs through, and they need to maintain regulatory control over the products so consumers aren’t aware that there may be side effects (800 reports and you didn’t say anything Matrixx?).

And homeopathic medicines are really only the beginning in the story of unregulated medicines.  Herbal supplements and vitamins are a hugely popular market and I guarantee that not you, I, or the person who produced the pills could tell you exactly what was in it.  There is no strict quality assurance guidelines, there are no tests to see the efficacy.  And just because something is herbal does not mean that it is not powerful.  Paclitaxel™ is a herbal product with these side effects:

nausea and vomiting, loss of appetite, change in taste, thinned or brittle hair, pain in the joints of the arms or legs lasting 2–3 days, changes in the color of the nails, tingling in the hands or toes. More serious side effects such as unusual bruising or bleeding, pain/redness/swelling at the injection site, change in normal bowel habits for more than 2 days, fever, chills, cough, sore throat, difficulty swallowing, dizziness, shortness of breath, severe exhaustion, skin rash, facial flushing and chest pain can also occur.

Paclitaxel™ is used in the UK currently as a chemotherapeutic agent for the treatment of ovarian, breast, and lung cancer.  Pretty powerful stuff for just a little herbal based extract.

Wow, this post has gone of too long but I hope just a few people can read it and get an idea of the problems that physicians face when dealing with these types of products which are allowed to skate around the very important tests (like if they actually do anything, or if something in them reacts violently in combination with another drug, etc.) that are the gold standard of medicine today.  So be kind to your doctor and don’t take supplements unless he recommends a specific one, I know they all claim to work wonders but they probably don’t.  And I only say probably because nobody has a damn clue if they do much of anything.

Oh, and it is homeopathy awareness week so be aware that it is all a scam, a very lucrative and dangerous one at that.