I’ve been blogging for over three years and Cold-fX, a popular Canadian ginseng supplement, was one of the first topics I tackled. The omnipresent Canadian advertising, huge pharmacy presence, and impressive-sounding efficacy claims made it an ideal case study. Perhaps not surprisingly, when I reviewed the data, the results didn’t hold up: I concluded that in a best case scenario, you’d need to take Cold-fX for four cold seasons (about 16 months) to prevent a single cold. And while the manufacturer claimed that Cold-fX could actually stop colds once they’d started, I noted that there was no published evidence to back up that claim. I concluded there was was little rationale to justify supplementing with Cold-fX. The published clinical evidence wasn’t persuasive, and the supplement is not inexpensive. The smarter strategy? Washing your hands regularly is clinically proven, and it’s a lot less expensive.
Since my review, the popularity of Cold-fX has continued unabated. And the manufacturer has branched out into all kinds of supplements: Cell -fX (shark cartilage), Cold Sore fX (bee propolis), Remember-fX (also ginseng), Memory-fX (more ginseng), and Immunity-fX (ginseng again, but with with reishi mushroom). Skeptical yet? So was CBC’s Marketplace, which scrutinized Cold-FX in a episode broadcast earlier this month. (I can’t embed the video, so you’ll need to watch the video at the CBC’s site.) For those of you that haven’t seen Marketplace, it’s a consumer affairs/consumer advocacy show that takes on medical topics from time-to-time. Last year it did an excellent investigation of the elaborate placebo system known as homeopathy. The producers are clearly science and consumer advocates, making natural health products low-hanging fruit. So Cold-fX was a fitting topic. Their investigation focused on several issues:
The Marketing, which prominently features Canadian hockey personality Don Cherry. The extended interview with Cherry must be seen to be believed. There are also several segments where consumers are asked about their understanding of how Cold-fX works, and how it should be taken. Clearly, the marketing has been very effective.
The Approval Process, which highlights that Cold-fX is not approved by Health Canada for a large dose to be taken for “immediate relief”, yet it is marketed this way. It is only approved for prevention purposes, at a dose of one capsule twice daily, with the following wording:
Helps reduce the frequency, severity and duration of cold and flu symptoms by boosting the immune system.
(Yes, that’s Health Canada’s Natural Health Products Directorate, endorsing the “boost” your immune system gambit.)
Despite Health Canada’s restrictions, the manufacturer has labelled and promoted Cold-fX for “immediate use” for several years. The manufacturer tells Marketplace that this is a labelling issue – one that the company has been working out on “phasing out”, apparently for the past five years. Can you imagine a pharmaceutical company developing a drug, then ignoring its own marketing approval, and labeling and advertising it for an unapproved use, with an unapproved dose, for five years? It simply would not happen. But when it comes to Health Canada’s Natural Health Products Directorate, which licenses Cold-fX and other natural health products in Canada, there’s clearly a different standard in place – one in which the safety and efficacy requirements for approved products are questionable, and even more disappointingly, seemingly not even enforced.
It’s on this point that I wanted to see Marketplace do some more digging. It is Health Canada’s approval that we are told should give both health professionals and consumers confidence in natural health products. Yet should we have any? If the Natural Health Products Directorate (NHPD) is to serve any purpose it all, it should at a minimum ensure that approved products are manufactured to high quality standards and labelled consistently with what’s approved. Otherwise, what is the point of registering and approving natural health products? Here is what the NHPD promises:
Through the Natural Health Products Directorate, Health Canada assures that all Canadians have ready access to a wide range of natural health products that are safe, effective and of high quality. We assess all natural health products before letting them be sold in Canada. We also check that NHPs are properly manufactured (without contamination or incorrect ingredients). And we do post-market monitoring to make sure that NHP Regulations are being followed.
They also state:
It is Health Canada’s expectation that natural health products are sold in accordance with their Terms of Market Authorization. Any necessary changes to labels are expected within a reasonable period of time (e.g. the lesser of next label run or 12 months) if no risk to the health and safety of Canadians is identified. Product license holders should take the necessary steps to ensure compliance with these expectations.
Yet, that didn’t occur, and it’s still not occurring. With Cold-FX, it’s been 144 months since the product was first marketed. How much longer should we expect to wait to see enforcement of the Regulations?
Pharmacist Recommendations: Pharmacist after pharmacist is secretly filmed stating that Cold-FX should be taken at the onset of a cold, with some pharmacists claiming that there is evidence to support this use. Here they’re giving the marketing line – not an evaluation of the actual evidence. The Canadian Pharmacists Association’s president, Jody Shkrobot is asked to explain these recommendations. He notes that pharmacists should be recommending the product according to Health Canada’s indications – which clearly states that Cold-Fx is approved for prevention purposes only. While I don’t excuse pharmacists for not knowing the clinical data for the products they recommend, I am somewhat sympathetic here. Cold-fX has been approved for sale, by Health Canada, for several years – yet Health Canada has never enforced proper labelling. So pharmacists may be assuming that the “immediate relief” dosing regimen on the label has been reviewed and approved – which is a legitimate assumption, given Cold-fX has a natural product number (NPN) also on the label, signifying Health Canada’s regulatory approval. And despite this labelling issue being identified and noted for several years, Health Canada (to my knowledge) has never sent any communication to consumers or health professionals drawing their attention to this fact.
The Evidence: There’s a brief interview with Dr. Andreas Laupacis who notes that there are no published clinical trials that have studied Cold-fX to treat colds in those that notice cold symptoms. CBC then commissioned a meta-analysis by pharmacist Lane Ilersich to combine and analyze four published clinical trials – all for the prevention of infections. Three of these papers I reviewed back in 2009, and one more has been published since that time: Efficacy and Safety of CVT-E002, a Proprietary Extract of Panax quinquefolius in the Prevention of Respiratory Infections in Influenza-Vaccinated Community-Dwelling Adults: A Multicenter, Randomized, Double-Blind, and Placebo-Controlled Trial. It was published in the open access journal Influenza Research and Treatment, which from what I can see, does not appear to be abstracted in PubMed – not a promising sign. The clinical bottom line of this study is largely consistent with the other studies: No difference between Cold-Fx and placebo for the prevention of laboratory confirmed infections. So my advice to consumers remains the same: There little evidence that Cold-fX, even for its approved use, has any clinically meaningfully effects. (I’ll try to come back to the meta-analysis at a later date and do a more detailed review.)
The Manufacturing: Cold-fX is labelled as a Canadian product. It is revealed that some parts of the manufacturing process takes place in China, somewhat contrary to the “Proudly Canadian” labelling. It ‘s also revealed that a liquid formulation of the product, never marketed, was found to be contaminated with Enterococcus faecium, which may have meant that fecal matter, or some source of this bacteria, was contaminating the supply. While the new liquid product, all 375,000 bottles, were pulled from marketing, Marketplace says the contaminated powder was still packaged and sold to consumers – in violation of Health Canada’s standards. There’s also mention of an audit of the Chinese plant, warning of manufacturing issues. Marketplace further notes that Health Canada was tipped off and did test seven bottles for contamination. They didn’t find E. faecium but they did find it contaminated with low levels of Escherichia hermannii, yet allowed the product to remain for sale. The manufacturer disputes these findings. So does the manufacturing process for Cold-fX follow regulations, or not? It’s not clear. Disappointingly, there is no follow-up on Health Canada’s inaction here, either.
When it comes to scrutinizing the claims and evidence for marketed natural health products in Canada, Marketplace could devote every single episode to Canadian supplements and never run out of topics. Skeptic North blogger Erik Davis illustrated this point nicely with his series of Health Canada Approves posts. Marketplace did a thorough job of showing that when it comes to Cold-fX, the clinical evidence is lacking, and the regulations in place to protect Canadians aren’t being followed. So why not go to the source of the problem: Health Canada’s Natural Health Products Directorate, which assures us that approved natural health products are “safe, effective, and of high quality”. Given the NHPD also approves indistinguishable sugar pills for therapeutic purposes, perhaps it’s time to start asking the regulator to start looking out for consumers, too.
For another take on the Marketplace episode, check out Kim Hébert’s review at Skeptic North.