The unsubstantiated claim that cold symptoms will be reduced within days of taking Cold-FX is at the heart of a lawsuit initiated by my new hero, Vancouver Island resident Dan Harrison. His notice of claim states that Valeant, the parent company, continued to “knowingly or recklessly” promote Cold-FX despite evidence that it works no better than a placebo. The company website states that “COLD-FX has been found to be highly effective in reducing … cold and flu symptoms.” Highly effective is not exactly accurate as only one poorly done study suggested a slight positive impact after being taken daily for prolonged periods but, as we shall see, that’s not a great idea. The folks at Science-Based Pharmacy explain how questionable manipulation of statistics fooled people, including many physicians, into believing there might be clinical proof that it works. But it doesn’t. The bottom line, as they see it, is that there is “no difference between Cold-FX and placebo for the prevention of laboratory confirmed infections”. Many of their studies rely on self-reported symptoms, but we all know that this kind of data collection is flawed and largely unreliable. Moreover, all the studies have been conducted by the company itself and the quality of data and manipulation of statistics have been widely criticized. Scott Gavura, of Science-Based Medicine, says the data “don’t show any meaningful effects” for cold symptom relief and points out that influenza protection hasn’t been specifically studied. The published clinical evidence is not persuasive.
Cold-FX also promises to “boost your immune system”. I honestly had trouble typing that phrase, it’s so repugnant. There are no published studies on the purported mechanism of action for Cold-FX, so they have no right to pretend to know the mechanism of action. Studies on ginseng, the main ingredient, similarly show it has no effect on immunity. Regular readers will recall that there are only two ways to “boost” an immune system. The simplest is to challenge your immune system with a pathogen, either by getting a vaccination or an infection, and waiting for the body to stock up on reserve cells that will better fight that pathogen in the future. A more difficult method is to inject pre-made antibodies or immune cells from an outside source to help your immune system when it is having trouble. There is no, I repeat NO, food or supplement that improves immune function, unless you are allergic to it, but that is not the boost you are looking for.
The website unabashedly announces that “Cold-FX provides further symptom reduction when taken with a flu shot”. Flu shots reduce flu symptoms when taken along with a stubbed toe too, so that’s hardly a claim worth making. At least they are promoting vaccinations. If you are deficient in a vitamin required by immune cells, supplements may restore normal function. However, this will only bring your immune system back up to normal – there is no “super immunity” after that. Supplements can cause harm, so you should not diagnose and prescribe them for yourself. Take them only under the direction of a real physician, not a naturopath.
Cold-FX claims it is a “clinically-proven formula”, but there was only one study done on the active ingredient and that was a small, poorly designed one published in a low quality, pay-to-publish journal which has been criticized for its lack of rigour. It is not even listed in PubMed, the medical research hub. They claim to have a decade’s worth of studies but they don’t link to any of them. What are they hiding? The Cochrane Review did a meta-analysis of products with Ginseng and pointed out that “trials were found to have multiple problems” and findings were inconsistent. They conclude that there is no clinical evidence for benefit from Cold-FX. You can see why Mr. Harrison is upset with their labelling.
What are the ingredients in this product that claims to cure the common cold? First on the label is Andrographis paniculata, an extremely bitter herb used in the pseudoscientific practice of ayurveda. The Mayo Clinic offers this warning about the herb: “Pregnant women shouldn’t use Aandrographis because it could terminate pregnancy.” WebMD lists these side effects: “loss of appetite, diarrhea, vomiting, rash, headache, runny nose, and fatigue.” It can cause cold-like symptoms! WebMD adds that: “When used in high doses or long-term, Andrographis might cause swollen lymph glands, serious allergic reactions, elevations of liver enzymes, and other side effects”. It can also cause “slow blood clotting”. This makes the company’s advice that adults should take up to 9 capsules per day for prophylaxis is a bit suspect.
The second ingredient in is zinc, a mineral important for cell metabolism, required in minute amounts in the diet. It’s very dangerous in large amounts, however, as the makers of another product learned the hard way. Zicam also alleged that zinc could protect against colds but after many of their customers lost their sense of smell, they lost big in a lawsuit. Zicam had to relaunch their product without the main ingredient, zinc. Now it’s homeopathic!
Echinacea is also on the ingredient list of COLD-FX but that herb has been so thoroughly debunked as a cold remedy I won’t waste space on that here. Plus there is not enough of the plant grown in the world to fill all the capsules that supposedly contain it.
The last active ingredient listed is their proprietary extract of American Ginseng, a plant that is rare now in North America because of all the harvesting for herbal products. Ginseng, like Echinacea, has not been shown to be of any medicinal use whatsoever, but Big Herbal, no doubt motivated by the huge profits to be made, continues to exaggerate its benefits.
The best advice about colds was probably given to you by your grandmother, if you were lucky enough to have known one. Eat properly and get enough sleep. If you do get a cold take it easy for a few days and it will go away. Get flu shots and wash your hands to ward off the flu. Don’t waste money on potentially dangerous, unregulated, herbal products that keep getting in legal trouble. Incidentally, the suit has cost Valeant Pharmaceuticals a lot of money. It also cost a few friends of mine who invested in Valeant. The endorsement of Cold –FX by Don Cherry should have been a red flag but they missed it.
In the wake of the lawsuits and restrictions from health Canada, the COLD-FX has finally taken many of their unsubstantiated claims off labels and websites. Now it’s time to pressure Health Canada to fully embrace science-based medicine and stop approving products like these. Health Canada’s Natural Health Products Directorate assures us that the natural health products they approve are “safe, effective, and of high quality”. Since CBC’s Marketplace Episode on nosodes revealed, they will approve sugar pills, with no evidence for efficacy whatsoever. Health Canada has protected homeopaths and natural health products for too long. It’s time they started protecting Canadian consumers.
FDA advises against Zicam: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm167065.htm
CBC Marketplace Cold-FX show: http://www.cbc.ca/marketplace/episodes/2012-episodes/what-fx